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348 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : CASTA-DIVA P141204
Spécialité : Autres
Traitement : Protocole de traitement
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Patients with active cancer and symptomatic pulmonary embolism, proximal deep vein thrombosis, iliac or caval thrombosis will be randomly assigned to receive either dalteparin using the CLOT regimen or to oral rivaroxaban using the conventional dosage given in the Einstein studies. Experimental and control treatments will be given for three months.

•Active Comparator: Low-molecular-weight heparin
dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months
Intervention: Drug: Low-molecular-weight heparin

•Experimental: Rivaroxaban
rivaroxaban, orally, 15 mg twice daily for 3 weeks followed by 20 mg once daily for 9 weeks

Informations

Traitement des thromboses veineuses

associé à des tumeurs solides ou myélome

Traitement anticoagulant

Phase: 3

Promoteur: Assistance Publique - Hôpitaux de Paris
Autre(s) acronyme(s): P141204
Contact promoteur: Contact: Guy Meyer, MD
Contact: Christine Lanau
Mail promoteur: guy.meyer@aphp.fr
christine.lanau@aphp.fr

Contact à BREST: Aurelien DELLUC aurelien.delluc@chu-brest.fr
-
Source: Clinical trials 10/10/2016"

Cet essai dans d'autres annuaires :

Titre :

Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.

Critères d'inclusion :
  1. Age > 18 years

  2. Social security affiliation

  3. Written informed consent

  4. Solid active cancer or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.

  5. Histologically or cytologically proven cancer.

  6. Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally

  7. High-risk of recurrent Venous thromboembolism (VTE) defined by a score ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) tumor stage 1 (-2), previous VTE (+1).

Critères de non-inclusion :
  1. Exclusive adjuvant hormonal treatment with no measurable residual disease

  2. Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT

  3. Isolated distal deep vein thrombosis (DVT) of the legs

  4. Isolated upper-extremity DVT or superior vena cava thrombosis

  5. Isolated visceral thrombosis

  6. Platelet count < 50 000 G/L

  7. Active bleeding

  8. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C

  9. Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage

  10. Vena cava filter at inclusion

  11. Fibrinolytic therapy within 3 days preceding inclusion

  12. Creatinine clearance < 30 ml/min according to Cockcroft-Gault formula

  13. Previous heparin-induced thrombocytopenia

  14. Anticoagulant treatment at curative dosage for more than 3 days before inclusion

  15. Pregnancy or lack of effective contraceptive treatment for women of childbearing age

  16. Contraindication to the use of contrast medium

  17. Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole

  18. Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.

  19. Life expectancy < 3 months

  20. Eastern Cooperative Oncology Group (ECOG) level 3 or 4

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr Delluc Aurélien - Mme Fortin-Prunier - helene.fortin-prunier@chu-brest.fr

Coordinatrice

/ Oui 10/10/2016
Afficher les détails
Acronyme : CC95775 CC-95775-ST-001 U1111-1238-6062 2019-001092-36
Spécialité : Autres
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase Ib
Descriptif

Experimental: CC-95775
Escalating dose finding part A of study and extension Part B of the study. In Part A, subjects will be treated with oral capsules of CC-95775 with a schedule of 4d on/ 24d off (Q4W) and a starting dose of 100 mg/day on a 28-day cycle. Dose increments between cohorts will not exceed 100% of the dose in previous cohort. Patients in Part B will be treated with a schedule of 4d on/24d off (Q4W) at the Maximum tolerated dose (MTD) established from Part A.
Intervention: Drug: CC-95775

Informations
Toutes tumeurs solides avancées
Lymphome non hodgkidien refractaire/rechute

Phase 1B

Promoteur: Celgene
Contact: Pilar Lardelli, MD PhD 34 605209083 plardelli@celgene.com
Contact: Zariana Nikolova, MD PhD 41 327298441 znikolova@celgene.com

Cet essai dans d'autres annuaires :

Titre :

A PHASE 1B DOSE ESCALATION, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC OF CC-95775 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY NON-HODGKIN'S LYMPHOMA

Critères d'inclusion :
  1. Men and women ≥ 18 years of age, at the time of signing the ICF.

  2. Subject must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.

  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

  4. Subjects with histological or cytological confirmation of either:

    Advanced or unresectable ST, laBCC or R/R NHL.

    Subjects with solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists.
     
    Subjects with laBCC must have unresectable disease which must have progressed after treatment with a smoothened inhibitor (SMOi) or who are intolerant of SMOi on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity).
     
    For relapsed/ refractory NHL following at least 2 prior lines of therapy (e.g. subjects have failed at least one line of standard therapy and have received at least one prior line of salvage therapy) OR have failed at least one prior line of standard therapy and are not eligible for autologous stem cell transplant (ASCT) OR have declined ASCT; transformed lymphoma following chemotherapy for lower grade lymphoma and at least one standard treatment regimen for DLBCL.
     
    Subjects with two or more lines of systemic therapy who have been treated with and have lack of response or have responded and relapsed after chimeric antigen receptor T-cell (CAR-T) therapy, if such therapy is available, OR are ineligible for CAR-T therapy at the time of enrollment, OR declined CAR-T therapy.
     
    Subjects must have at least one site of measurable disease according to RECIST 1.1 Previously irradiated lesions are not considered evaluable; for subjects with R/R NHL, bi-dimensionally measurable disease on cross sectional imaging by CT or MRI, with at least one lesion >1.5 cm in its greatest transverse diameter, as defined by the IWG criteria. For subjects with rare malignancies, not falling into the above categories and who might benefit from a treatment with BET inhibitor, evaluable disease can be considered.
  5. Subjects consent to tumor archive material analysis. Tumor biopsies to be collected whenever safe and feasible will be collected in Part A. Subjects consents to mandatory tumor biopsies (Screening and on treatment) in Part B.

  6. ECOG PS of 0 to 1.

    Subjects must have the following laboratory values at Screening:

    Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if subject received peg-filgrastim).
    Hemoglobin (HGB ≥10 g/dL (≥ 8g/dL for DLBCL subjects).
    Platelet count (PLT) ≥150 x 109/L (≥100 x 109/L without transfusion for 7 days for DLBCL subjects).
    Serum potassium concentration within normal range, or correctable with supplements
    Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≤ 3.0 x Upper Limit of Normal (ULN).
    Serum total bilirubin ≤ 1.5 x ULN.
    Serum creatinine ≤ 1.5 x ULN or measured glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr EDTA or 1125 iothalamate, or creatinine clearance of ≥ 50 mL/min using Cockroft-Gault equation.
    Subjects must have serum albumin > 3.5 g/dL.
    PT (or INR) and APTT within normal range.
  7. Subjects must agree not to share study drugs with another person

  8. Females of childbearing potential

    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or other medical condition does not rule out childbearing potential) for at least 12 consecutive months and verified by an FSH blood test at screening.
    FCBP must either commit to true abstinence from heterosexual intercourse (which must be reviewed monthly and source documented) or to use one highly effective contraceptive method plus one barrier method. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Highly effective contraceptive methods are combined (containing estrogen and progestogen) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, intravaginal, patch, or implantable); bilateral tubal ligation; intrauterine device; intrauterine hormone-releasing system; or vasectomized partner sterilization (note that vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success). Barrier methods are male or female latex or synthetic condom, diaphragm, cervical cap or sponge with spermicide, barrier contraceptive with spermicide. These measures should be used from signing the ICF, throughout the study, and for up to 44 days following the last dose of CC-95775.
    Have two negative pregnancy tests as verified by the investigator prior to starting CC-95775.
    Pregnancy testing:
    A negative serum pregnancy test (or β-subunit of human chorionic gonadotropin (β-hCG pregnancy test) at Screening verified by the Investigator.
    A negative serum or urine pregnancy test (or β-subunit of human chorionic gonadotropin (β-hCG pregnancy test) on Day 1 of dosing verified by the Investigator prior to dosing.
    Agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
  9. Male subjects must practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom (a latex or non-latex synthetic condom is required) during sexual contact with a pregnant female or a FCBP and will avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 104 days following CC-95775 discontinuation, even if he has undergone a successful vasectomy. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject [female partner's periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

    Males must agree not to donate semen or sperm for at least 104 days following CC-95775 discontinuation.
    Other than the subject, FCBP and males able to father a child should not handle the study drugs or touch the capsules, unless gloves are worn.
Critères de non-inclusion :
  1. Subject has received anti-cancer therapy (either approved or investigational) within ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to starting CC-95775.

    • < 42 days for prior nitrosureas or mitomycin C

  2. Toxicities resulting from prior systemic cancer therapies must have resolved to ≤ NCI CTCAE Grade 1 prior to starting CC-95775 treatment (with exception of Grade 2 peripheral neuropathy and alopecia).

  3. Subject has received autologous hematologic stem cell transplant (HSCT) ≤ 3 months prior to starting CC-95775 treatment. Subjects with allogeneic HSCT will not be allowed on this protocol.

  4. Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to starting CC-95775 or who have not recovered from surgery.

  5. Subject has completed any radiation treatment < 4 weeks prior to starting CC-95775 (with exception of palliative bone radiotherapy for which 2-week period is required).

  6. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of CC-95775.

  7. Subjects with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.

  8. Subjects with symptomatic or uncontrolled diabetes mellitus.

  9. Symptomatic, untreated, or unstable central nervous system (CNS) metastases, (except in case of CNS primary tumors).

    Subjects recently treated with whole brain radiation or stereotactic radiosurgery for CNS metastases must have completed therapy at least 4 weeks prior to starting CC-95775 and have a follow-up brain CT or MRI demonstrating either stable or improving metastases 4 or more weeks after completion of radiotherapy (the latter to be obtained as part of the Screening Assessments.

    Subjects must be asymptomatic and off steroids or on stable dose of steroids for at least 4 weeks (<4 mg/day dexamethasone or equivalent) or on tapering dose of steroids.

  10. Known symptomatic acute or chronic pancreatitis.

  11. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

    LVEF < 45% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).
    Complete left bundle branch or bifascicular block.
    Congenital long QT syndrome.
    Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation.
    QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings).
    Unstable angina or myocardial infarction ≤ 6 months prior to starting CC-95770.
    Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).
  12. Pregnant or nursing females.

  13. Known HIV infection

  14. Known chronic active hepatitis B or C virus (HBV, HCV) infection.

    Subjects who are seropositive due to HBV vaccination are eligible.
    Subjects who have no active viral infection and are under adequate prophylactics against HBV re-activation are eligible.
    Subjects with HCC are exempt from the above criteria.
  15. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonists). Low dose, low molecular weight heparin for catheter maintenance is allowed.

  16. History of concurrent second cancers requiring active, ongoing systemic treatment.

  17. Subjects with a history of clinically significant cognitive disorder(s) or active cognitive disorder(s).

  18. Evidence of history of bleeding diathesis. Any hemorrhage/bleeding event > CTCAE Grade 2 or hemoptysis > 1 teaspoon within 4 weeks prior to the first dose

  19. Subject has any significant medical condition (e.g., active or uncontrolled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating (or compromise compliance) in the study or would place the subject at unacceptable risk if he/she were to participate in the study.

  20. Subject has any condition that confounds the ability to interpret data from the study.

  21. Subjects with poor bone marrow reserve as assessed by the Investigator such as in the following conditions:

    Having received extensive bone radiotherapy
    Having experienced several episodes of bone marrow aplasia in previous treatments
    Confirmed histological bone marrow cancer infiltration (with exemption of NHL)
    Requiring regular hematopoietic support (blood transfusion, erythropoietin, G-CSF)
  22. Subjects with severely compromised pulmonary function and/or requiring chronic oxygen administration

 

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Thierry Lesimple - Christelle NICOLLE - c.nicolle@rennes.unicancer.fr / Oui 10/01/2020
Rennes - CLIP² Dr Thierry Lesimple - Damien Denis - damien.denis@chu-rennes.fr / Oui 13/11/2019
Afficher les détails
Acronyme : Cupisco Cupisco-capi 2017-003040-20 NCT03498521
Spécialité : Autres
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Molecularly-Guided Therapy
Participants will be assigned molecularly-guided therapy based on genetic profile.

Drug: Alectinib
Drug: Vismodegib
Drug: Ipatasertib
Drug: Olaparib
Drug: Erlotinib
Drug: Bevacizumab
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Atezolizumab
Active Comparator: Platinum-Based Chemotherapy


Participants will receive platinum-doublet) chemotherapy (Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, or Carboplatin/Gemcitabine)

Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Cisplatin
Drug: Gemcitabine

Informations

Cancer of unknown primary site (CUP)

1ère ligne

Phase: 2

Promoteur: Hoffmann-La Roche
Autre(s) acronyme(s): Cupisco
Cupisco-capi
2017-003040-20
NCT03498521
Contact promoteur: Hoffmann-La Roche
Mail promoteur: global-roche-genentech-trials@gene.com

Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

Critères d'inclusion :
  1. Histologically-confirmed cancer of unknown primary site (CUP)(non-specific subset) according to criteria from the European Society for Medical Oncology, version 1 (ESMO v1)

  2. Each patient must provide a blood sample for genomic profiling

  3. No prior lines of systemic therapy for the treatment of CUP

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  5. Candidate for platinum-based doublet chemotherapy (according to the reference information for the intended doublet therapy)

  6. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors, version 1.1 (RECIST v1.1)

  7. Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample that is sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory

Critères de non-inclusion :
  1. Squamous cell CUP

  2. History or known presence of leptomeningeal disease

  3. Known human immunodeficiency virus (HIV) infection

  4. Significant cardiovascular disease

  5. Prior allogeneic stem cell or solid organ transplantation

  6. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 24 months after the last dose of study treatment

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr E. Vauléon - Sophie Gimenez - s.gimenez@rennes.unicancer.fr NC / NC Oui 21/05/2019
Afficher les détails
Acronyme : "API-CAT APICAT-Tumeurs solides P170604J NCT03692065 "
Spécialité : Autres
Traitement : Protocole de traitement
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Apixaban film coated tablets 2.5 mg
Patients randomized in the apixaban reduced dose group will receive an apixaban 2.5 mg tablet and a placebo of apixaban 5 mg tablet, twice daily for 12 months.

Active Comparator: Apixaban film coated tablets 5 mgPatients randomized in the apixaban full dose group will receive a placebo of apixaban 2.5 mg tablet and an apixaban 5 mg tablet, twice daily for 12 months.

 

Informations

Phase: 3

Promoteur: Assistance Publique - Hôpitaux de Paris
Autre(s) acronyme(s): APICAT-Tumeurs solides
P170604J
NCT03692065
Contact promoteur: Isabelle Mahé, Pr
Sofiane DJAILEB, Mr

Mail promoteur: isabelle.mahe@aphp.fr
sofiane.djaileb@aphp.fr
Tel promoteur: 33 (0)1 47 60 64 90
33(0)1 57 27 84 58
Coordonnateur: Guy Meyer, Pr

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

Critères d'inclusion :
  1. Signed written informed consent

  2. Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)

  3. Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy at inclusion

  4. Objectively documented index event : Symptomatic or incidental proximal lower-limb, iliac, inferior vena cava DVT or symptomatic or incidental pulmonary embolism in a segmental or larger pulmonary artery or incidental PE in a segmental or larger pulmonary artery

    Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging

    PE has to be demonstrated by imaging as follows:

    an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography; or

    an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or

    a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).

  5. Completed at least 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing),or completed assigned a clinical trial study treatment, for the treatment of the index event and patient still receiving anticoagulant treatment 6 months after occurrence of the VTE index

  6. No objectively documented symptomatic recurrence of VTE between the index event and randomization.

  7. Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization

  8. Patient affiliated to social security for French centers.

Critères de non-inclusion :
  1. WOCBP who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study

  2. Women who are pregnant or breastfeeding

  3. Women with a positive pregnancy test on enrollment or prior to investigational product administration

  4. Isolated sub-segmental (incidental or symptomatic) PE without associated DVT

  5. Isolated distal DVT of the legs

  6. Isolated upper-extremity DVT or superior vena cava thrombosis

  7. Isolated visceral thrombosis

  8. Isolated catheter thrombosis

  9. Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment

  10. VTE during anticoagulant treatment given at therapeutic dosage

  11. Subjects with indications for long-term treatment with a VKA, such as:

  12. Mechanical heart valve

  13. Antiphospholipid syndrome

  14. Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage

  15. Conditions increasing the risk of serious bleeding

    intracranial or intraocular bleeding within the 6 months

    major surgery within 2 weeks prior to randomization

    overt major bleeding at time of randomization

  16. Life expectancy < 12 months

  17. Eastern Cooperative Oncology Group (ECOG) level 3 or 4

  18. Bacterial endocarditis

  19. Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg

  20. Platelet count < 75,000/mm3

  21. Hemoglobin < 8g /dl

  22. Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation

  23. Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range

  24. Subjects requiring acetylsalicylic acid >165 mg/day at randomization or thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor).

  25. Subjects requiring dual anti-platelet therapy (such as acetylsalicylic acid plus clopidogrel or acetylsalicylic acid plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial.

  26. Concomitant use of strong inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong inducers of both cytochrome P450 3A4 and P Glycoprotein (e.g.,rifampicin, carbamazepine, or phenytoin).

  27. Prisoners or subjects who are involuntarily incarcerated

  28. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

  29. Hypersensitivity to apixaban

  30. Subjects participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the coagulation system

  31. Under 18 years old

  32. Patients under legal protection (guardianship).

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Bettina BOUTRUCHE - Véronique BRIEUC - v.brieuc@rennes.unicancer.fr NC / NC Oui 23/08/2019
Afficher les détails
Acronyme : aXa
Spécialité : Autres
Traitement : Autres
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Il s’agit d’une étude prospective multicentrique (11 centres) avec :
- une étude de cohorte de 200 sujets hospitalisés pour MVTE et ayant un cancer
(suivis pendant 6 mois).
- une étude comparative de la pharmacocinétique de l’activité anti-Xa entre les 50
premiers sujets (de la cohorte) hospitalisés pour MVTE et ayant un cancer, et 50
sujets hospitalisés pour MVTE et indemnes de cancer, appariés (1-1) pour l’âge, la
fonction rénale et le sexe.

Informations

Phase: 3
Promoteur: A P - HÔPITAUX DE PARIS
Autre(s) acronyme(s): P100127
Contact promoteur: Nathalie Authesserre-Tachet, APHP
Mail promoteur: NR
Tel promoteur: NR
Coordonnateur: Pr. Guy Meyer, Hôpital Européen Georges Pompidou
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: Version N°6.0 du 19/12/2013

Titre :

Activité anti Xa chez les sujets atteints de cancers traités par héparine de bas poids moléculaire pour maladie veineuse thromboembolique (aXa).

Critères d'inclusion :
  • Patient hospitalisé pour MVTE

  • Traitement initial par une HBPM ou fondaparinux

  • Patient majeur

  • Affiliation à un régime de sécurité sociale

  • Consentement éclairé écrit

    Pour les cancéreux :

  • Cancer solide en évolution (maladie tumorale active ou résection tumorale incomplète ou marqueurs tumoraux restés élevés après résection complète).

  • Traitement par tinzaparine à dose curative.

    Pour les non cancéreux :

  • absence de pathologie tumorale maligne décelable à l’inclusion

Critères de non-inclusion :
  • Contre-indication au traitement curatif par HBPM

  • Traitement initial par une molécule anticoagulante autre qu’une HBPM ou du fondaparinux ( antithrombine directe, inactivateur direct du facteur Xa)

  • Insuffisance rénale (clairance à la créatinine < 30 ml/min)

  • Patient préalablement inclus dans l’étude

  • Grossesse, allaitement

  • Patient dont le poids est supérieur à 100 Kg

    Pour les cancéreux :

  • Maladie tumorale non confirmée histologiquement ou cytologiquement.

  • Suivi après résection tumorale complète sans élévation des marqueurs tumoraux

  • Espérance de vie < 6 mois

  • Suivi impossible

    Pour les non cancéreux :

  • Suspicion non encore confirmée de pathologie tumorale maligne associée à la MVTE.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site La Cavale Blanche Pr. F. Couturaud - francis.couturaud@chu-brest.fr Sophie Barillot - sophie.barillot@chu-brest.fr / Oui 23/04/2014
Afficher les détails
Acronyme : 18327 18327 2015-003897-33
Spécialité : Autres
Traitement : Thérapie ciblée néoadjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Drug: Anetumab ravtansine (BAY94-9343)
All subjects will receive anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks

Experimental: Anetumab ravtansine [hepatic control]
Subjects with adequate hepatic and renal function (controls)

Experimental: Anetumab ravtansine [mild impaired]
Subjects mild hepatic impairment (Child-Pugh Class A and eGFR [estimated glomerular filtration rate] ≥60 mL/min/1.73 m2)

Experimental: Anetumab ravtansine [moderate impaired1]
Subjects with moderate hepatic impairment (Child-Pugh Class B and and eGFR ≥60 mL/min/1.73 m2)

Experimental: Anetumab ravtansine [moderate impaired2]
Subjects with moderate renal impairment (eGFR 30 to <60 mL/min/1.73 m2)

Informations

ICO Nantes

mesothelin-expressing advanced solid cancers

predominantly epithelial (≥50% tumor component) pleural or peritoneal mesothelioma, epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible), adenocarcinoma of the pancreas, triple-negative adenocarcinoma of the breast, and non-small-cell adenocarcinoma of the lung. Subjects with resected primary cancers who have documented metastases are eligible.

Slots disponible au 24/10/17 : Groupe C 'moderate hepatic impairment'

Phase: 1

Promoteur: Bayer
Autre(s) acronyme(s): 18327 2015-003897-33
Contact promoteur: Bayer Clinical Trials Contact

Mail promoteur: clinical-trials-contact@bayer.com
Tel promoteur: NR
Coordonnateur: Bayer Study Director Bayer

-
Source: Clinical trials 12/01/2017"

Cet essai dans d'autres annuaires :

Titre :

An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

Critères d'inclusion :
  1. Male or female subjects aged ≥18 years

  2. Histologically confirmed, locally advanced or metastatic solid cancers of the following 5 histological types: predominantly epithelial (≥50% tumor component) pleural or peritoneal mesothelioma, epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible), adenocarcinoma of the pancreas, triple-negative adenocarcinoma of the breast, and non-small-cell adenocarcinoma of the lung. Subjects with resected primary cancers who have documented metastases are eligible.

  3. Subjects have no standard therapy available, or have actively refused standard therapy or, in the investigator's opinion, treatment in this study is clinically and ethically acceptable for the subject

  4. Subjects must meet the criteria for one of the 4 treatment groups:

    - Group A: Adequate hepatic and renal function (controls)

    - Group B: Mild hepatic impairment, i.e. Grade A according to the Child-Pugh Classification (total score of 5 or 6) and adequate renal function

    - Group C: Moderate hepatic impairment, i.e. Grade B according to the Child-Pugh Classification (total score of 7, 8 or 9) and adequate renal function

    - Group D: Moderate renal impairment, i.e. eGFR (estimated glomerular filtration rate) <60 and ≥30 mL/min per 1.73 m2 and hepatic function better than, or equal to mild impairment according to the Child-Pugh Classification (total score ≤6)

  5. Adequate bone marrow function

  6. Life expectancy of at least 12 weeks

  7. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 (control and mild hepatic impairment groups), or 0-2 (moderate hepatic impairment and moderate renal impairment groups)

Critères de non-inclusion :
  1. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated <3 years before the start of anetumab ravtansine

  2. New or progressive brain or meningeal or spinal metastases

  3. Gilbert's syndrome or other benign congenital hyperbilirubinemia (except for the control group), biliary cirrhosis or malignant biliary obstruction, unless the bile flow to the gastrointestinal tract is maintained by the fully operational biliary stent

  4. CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 bleeding within 4 weeks before the start of anetumab ravtansine

  5. Uncontrolled cardiovascular disease or hypertension.

  6. QTc interval >480 ms, heart rate ≥100 bpm or ≤45 bpm, LVEF (left ventricular ejection fraction) <50%

  7. Corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy

  8. Systemic anticancer therapy (except topical or intracavitary treatments with negligible absorption in systemic circulation) within 4 weeks before the start of anetumab ravtansine, or within 5 half-lives of the anticancer agent before the start of anetumab ravtansine, whichever is longer. Mitomycin C or nitrosoureas must be excluded within 6 weeks before the start of anetumab ravtansine.

  9. Radiotherapy within 4 weeks before the start of anetumab ravtansine

  10. Use of drugs with known renal or hepatic toxicity within 2 weeks before the start of anetumab ravtansine until the EoT (end of treatment) visit

  11. Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the start of anetumab ravtansine until the EoT visit

  12. Women who are pregnant or breastfeeding

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest GOURMELON Carole - BLANCHARD Gaelle - Gaelle.Blanchard@ico.unicancer.fr / Oui 11/05/2018
Afficher les détails
Acronyme : AcSé Nivo Acsé Nivolumab AcSé NIVO UC0105/1611
Spécialité : Autres
Traitement : Autres traitements exclusifs
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Experimental: Nivolumab

Nivolumab 240 mg IV over 60 minutes every 14 days.
Intervention: Drug: Nivolumab"

Informations
Cancer rare localement avancé ou métastatique ou réfractaire, inopérable
toutes lignes

Cohort 1: Non-clear cell RCC FERMEE 05/02/2019
Cohort 2: Rare head and neck cancer FERMEE 26/08/2019
Cohort 3: Rare skin cancer OUVERTE 05/02/2018
Cohort 4: MSI-nonCRC FERMEE 31/10/2018
Cohort 5: Penile cancer OUVERTE

Cohorte 6 : any non MSI-high cancer OUVERTE

Phase: 2

Promoteur: Centre Eugène Marquis
Autre(s) acronyme(s): Acsé Nivolumab AcSéNIVO-T. Solides UC0105/1611
Contact promoteur: Daniel Couch +fr

Mail promoteur: d-couch@unicancer.fr
Tel promoteur: +33 (0)1 80 50 12 96
Coordonnateur: Jean-Charles Soria, Prof. MD

Mail coordonnateur: jean-charles.soria@gustaveroussy.fr
Tel Coordonnateur: NR
-
Source: linicaltrials.org 03/08/2017"

Cet essai dans d'autres annuaires :

Titre :

Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Critères d'inclusion :
 
  1. "Patient information sheet and written informed consent form signed.

  2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types:

  3. Non-clear cell renal-cell carcinomas: papillary renal cell carcinoma (pRCC, type I, type II and non-classified pRCC), chromophobe RCC (ChRCC), renal medullary carcinoma (RMC), collecting duct/Bellini duct carcinoma (CDC), microphthalmia-associated transcription (MiT) family translocation renal cell carcinoma (tRCC), renal cell carcinoma with a prominent sarcomatoid component (sarcRCC).

  4. Rare head and neck cancers: principal and accessory salivary gland tumours, facial tissue tumours.

  5. Rare skin cancers: adnexal carcinomas, basal cell carcinoma resistant to vismodegib.

  6. Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR)

  7. Squamous cell carcinoma of penis.

  8. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator.

  9. Aged ≥ 18 years old.

  10. Measurable disease according to RECIST v1.1 guidelines for solid tumours (Eisenhauer, 2009).

  11. Able to provide a formalin fixed/paraffin embedded (FFP)E biopsy sample of a metastatic site or primitive tumour tissue.

  12. Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns).

  13. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments.

  14. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia.

  15. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1.0 x109/L, platelets ≥ 100 x109/L, haemoglobin (Hb) ≥ 9 g/L) measured within 14 days of treatment initiation.

  16. Adequate renal function (creatinine clearance ≥ 50 mL/ using the MDRD or CKI EPI method) measured within 14 days of treatment initiation.

  17. Adequate hepatic function (serum bilirubin ≤ 1.5 x the reference upper limit of normal (ULN) unless due to Gilbert's syndrome; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] ≤ 2,5 xULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤ 5x ULN is acceptable.

  18. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation.

  19. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 (Oken, 1982).

  20. Estimated life expectancy ≥ 90 days.

  21. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients.

  22. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required.

  23. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 90 days after the last administration of IP.

  24. Patients must be affiliated to a Social Security System or equivalent."

Critères de non-inclusion :
  1. "Prior treatment with an anti-PD1 or anti-PD-L1 antibody

  2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease which is open to accrual in France.

  3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent.

  4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

  5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

  6. History of severe hypersensitivity reaction to any monoclonal antibody therapy

  7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP.

  8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial.

  9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

  10. Has known carcinomatous meningitis or a history of leptomeningeal disease.

  11. Serum creatinine > 1.5 xULN or glomerular filtration rate (GFR) < 50 ml/min.

  12. Lymphocytes count below 1,000/mm3 and CD4+ count below 500/mm3 as assessed by routine blood phenotyping. Critère supprimé avec amendement n°3

  13. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix.

  14. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. amendement n°4 : les patients atteints d'une hépatite A, B ou C guérie ainsi que les patients atteints d'une hépatite B ou C chronique pourront dorénavant être inclus dans le protocole sous certaines conditions décrites dans le protocole.

  15. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus.

  16. Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.

  17. Active alcohol or drug abuse.

  18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.

  19. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Dupuy - Alain.DUPUY@chu-rennes.fr - 1 / 0 Oui 25/02/2019
NANTES - CHU Hépato-Digestif Dr Touchefeu Yann - DZIUKALA Catherine - / Non 12/06/2019
ANGERS - Institut de Cancérologie de l'Ouest ROLLAND Frederic - - / Oui 16/11/2018
Brest - CHU de Brest - Site Morvan - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr 1 / nc Non 24/06/2019
NANTES - Institut de Cancérologie de l' Ouest ROLLAND Frederic - - / Oui 24/08/2018
Rennes - Centre Eugène Marquis Dr Fanny Le Du - Enora Lejeune - / Oui 24/08/2018
Afficher les détails
Acronyme : AcSé Pembro UC0105/1612
Spécialité : Autres
Traitement : Traitement exclusif
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Experimental: Pembrolizumab
Pembrolizumab 200 mg IV as a 30 minute infusion on Day 1 of every 21 day cycle"

Informations
Tumeur rare localement avancé ou métastatique ou réfractaire, inopérable
Non prétraité par anti-PD1 or anti-PD-L1
toutes lignes avancé métastatique
 
 
Cohorte 1 : sarcome rare : Amendement 07/2019 : 10 patients présentant un chordome : fermée le 23/12/2019 -  sarcome rhabdoides/SMARCA4-, ou DSCRT (à partir de 15 ans) : fermée le 15/01/2020
Cohorte 2 : Cancer rare des ovaires : Fermée aux inclusions le 20/08/2019
Cohorte 3 : Lymphome primitif SNC : Fermée sauf lymphome primitif oculaire isolé
Cohorte 4 : Cancer rare de la thyroïde : Ouvert 03/04/2019
Cohorte 5 : Tumeur neuroendocrine rare  : Fermée aux inclusions 17/10/2019
Cohorte 6 : Cellules germinales  : Ouvert 03/04/2019
Cohorte 7 : Lymphome cellules T/NK :Ouvert 03/04/2019

 

Phase: 2

Promoteur: Unicancer
Autre(s) acronyme(s): AcSé Pembrolizumab UC0105/1612
Contact promoteur: Daniel Couch +fr

Mail promoteur: d-couch@unicancer.fr
Tel promoteur: +33 (0)1 80 50 12 96
Coordonnateur: Christophe.massard (remplace Jean-Charles Soria, Prof. MD AMDT n°1)

Mail coordonnateur: christophe.massard@gustaveroussy.fr

Source: clinicaltrials.org 03/08/2017"

Cet essai dans d'autres annuaires :

Titre :

Secured Access to Pembrolizumab for Adult Patients With Selected Rare Cancer Types (AcSé)

Critères d'inclusion :
  1. Patient information sheet and written informed consent form signed.

  2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types:

  3. Rare sarcoma: Alveolar soft part sarcoma, Chordoma, Dedifferentiated chondrosarcoma, epithelioid sarcoma, sarcoma with loss of INI1, malignant rhabdoid tumours, myxoid liposarcoma, angiosarcoma of the scalp, radiation induced sarcomas.

  4. Rare ovarian cancer: recurrent or relapsed; sex cord tumour, germ cell tumour (immature teratoma, non seminomatous germ cell & dysgerminoma), low-grade serous carcinoma, mucinous carcinoma, clear cell adenocarcinoma, small cell carcinoma, and carcinosarcoma - with histological confirmation following review by members of the Tumeurs Malignes Rares Gynécologiques (TMRG) network (French rare gynaecological tumour group)

  5. Primary central nervous system lymphoma (PCNSL): refractory primary intraocular and CNS lymphoma.

  6. Rare thyroid cancer: differentiated thyroid carcinoma (Papillary, follicular, Hurthle cell (oncocytic), poorly differentiated thyroid carcinoma), medullary thyroid carcinoma, anaplastic thyroid carcinoma.

  7. Rare malignant neuroendocrine tumour: poorly differentiated tumours refractory after 2 lines of chemotherapy, well differentiated tumours refractory after 4 lines of treatment, carcinoid tumours after 2 lines of treatment.

  8. Germ-cell cancer progressing after standard therapy.

  9. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator.

  10. Aged ≥ 18 years old.

  11. Measurable disease according to RECIST v1.1 guidelines for solid tumours (Eisenhauer, 2009); or IPCG response criteria (Abrey, 2005) for patients in the PCNSL cohort. For patients with germ-cell cancer measurable disease is defined as measurable according to RECIST v1.1 and / or abnormal levels of AFP, hCG and LDH.

  12. Able to provide a Formalin-fixed/paraffin-embedded (FFPE) biopsy sample of a metastatic site or primitive tumour tissue.

  13. Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns).

  14. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments.

  15. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia.

  16. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1.0 x109/L, platelets ≥ 100 x109/L, haemoglobin ≥ 9 g/L) measured within 14 days of treatment initiation.

  17. Adequate renal function (creatinine clearance ≥ 50 mL/min using the MDRD or CKI EPI method) measured within 14 days of treatment initiation.

  18. Adequate hepatic function (serum bilirubin ≤ 1.5 x the reference upper limit of normal (ULN) unless due to Gilbert's syndrome; ASAT and ALAT ≤ 2,5 xULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤ 5x ULN is acceptable.

  19. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation.

  20. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 (Oken, 1982).

  21. Estimated life expectancy ≥ 90 days.

  22. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of the investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients.

  23. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required.

  24. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 120 days after the last administration of IP.

  25. Patients must be affiliated to a Social Security System or equivalent.

Critères de non-inclusion :
  1. Prior treatment with an anti-PD1 or anti-PD-L1 antibody

  2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease which is open to accrual in France. (Amendement n°1 : clarification de ce critère)

  3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent. For patients with PCNSL or germ-cell cancer, concurrent steroid medication at a dose greater than prednisone 20 mg/day or equivalent.

  4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

  5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

  6. History of severe hypersensitivity reaction to any monoclonal antibody therapy

  7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP.

  8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial.

  9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

  10. Has known carcinomatous meningitis or a history of leptomeningeal disease, except for patients with primary CNS lymphoma.

  11. Serum creatinine > 1.5 xULN or glomerular filtration rate (GFR) < 50 ml/min.

  12. Critère supprimé avec AMDT n°1 : Lymphocytes count below 1,000/mm3 and CD4+ count below 500/mm3 as assessed by routine blood phenotyping.

  13. Other malignancies within the past 5 years other than basal cell skin cancer or in situ carcinoma of the cervix.

  14. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy.

  15. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus.

  16. Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.

  17. Active alcohol or drug abuse.

  18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.

  19. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
ANGERS - Institut de Cancérologie de l'Ouest Dr SOULIE Patrick - - / Oui 29/06/2018
Lorient - Centre Hospitalier Bretagne Sud Dr Isabelle Cumin - Mariella Le Saux - m.lesaux@ch-bretagne-sud.fr

Tel: 02.97.06.96.94

NC / NC Oui 11/02/2019
Brest - CHU de Brest - Site Morvan Dr. A. Tempescul - Guillaume Drugmanne - guillaume.drugmanne@chu-brest.fr 2 / nc Non 24/06/2019
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Roch Houot - BOZZOLA Nathalie - Nathalie.BOZZOLLA@chu-rennes.fr 6 / nc Oui 18/02/2019
NANTES - Institut de Cancérologie de l' Ouest BOMPAS Emmanuelle - RABREAU Catherine - Catherine.Rabreau@ico.unicancer.fr / Oui 11/05/2018
Rennes - Centre Eugène Marquis Dr Marc Pracht - Enora Lejeune - / Oui 24/06/2019
Afficher les détails
Acronyme : "PRAKYFRA-01-T.Solides PRAKYFRA-01 2018-002293-44"
Spécialité : Autres
Traitement : Palliatif / Soins de support
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

Randomisation : AKYNZEO versus traitement de référence incluant l'EMEND

Informations

Cancer tumeur maligne solide

Soins de support 

Phase: sans
Promoteur: VIFOR France
Autre(s) acronyme(s): PRAKYFRA-01-T.Solides PRAKYFRA-01
2018-002293-44
Contact promoteur: CAPIONIS
Mail promoteur: stephane.ouary@capionis.com
Tel promoteur: 33662755802
Coordonnateur: NR
-
Source: EU Clinical Trial Register

Cet essai dans d'autres annuaires :

Titre :

A Pragmatic randomized study to evaluate the comparative effectiveness of Akynzeo® and Standard of care (including Emend®) for the prevention of nausea and vomiting (CINV) in cancer patients receiving moderately emetogenic chemotherapy in France

Critères d'inclusion :
  1. Informed consent of the patient 

  2. Male or female, Age ≥ 18 years

  3. Have a histological or cytological confirmed solid tumor malignancy 

  4. Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor 

  5. Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator’s

  6. Naïve of CT

  7. ECOG performance up to 2

  8. Able to read, understand and follow the study procedures

Critères de non-inclusion :
  1. Pregnancy;

  2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Claire LARIBLE - Enora Michel - e.michel@rennes.unicancer.fr NC / NC Oui 08/01/2019
Afficher les détails
Acronyme : D 5160 C 00035
Spécialité : Autres
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: Normal renal function
For inclusion in the study as a patient with normal renal function, patients must have creatinine clearance ≥90 mL/min.
Drug: Osimertinib; AZD9291
80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
Other Name: TAGRISSO™


Experimental: Severe renal impairment
For inclusion in the study as a patient with severe renal impairment, patients must have stable severe renal impairment (creatinine clearance <30 mL/min), as defined by the Cockcroft Gault equation, for at least 2 months prior to Day 1.
Drug: Osimertinib; AZD9291
80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
Other Name: TAGRISSO™

Informations

Toutes tumeurs solides

2 cohortes : patients avec fonction rénale insuffisante (Clearance COK<30 mL/mn)

patients avec fonction rénale normale

Laboratoire Astra Zeneca

clinicaltrials.gov du 22/12/2017

Contact: AstraZeneca Clinical Study Information Center
 1-877-240-9479
 information.center@astrazeneca.com

Cet essai dans d'autres annuaires :

Titre :

Open-label,Non-randomised,Multicentre,Phase I Study to Assess the Pharmacokinetics, Safety & Tolerability of Osimertinib Following a Single Oral 80mg Dose to Patients w/ Adv Solid Tumours & Normal Renal Function or Severe Renal Impairment

Critères d'inclusion :
  1. For inclusion as a patient with severe renal impairment patient must have stable severe renal impairment (CrCl <30 mL/min at screening), for at least 2 months prior to the study.

  2. For inclusion as a patient with normal renal function, patient must have CrCl ≥90 mL/min at screening.

  3. >18 years old

  4. Histological or cytological confirmation of a solid, malignant tumour (excluding lymphoma) that is refractory to standard therapies or for which no standard therapies exist. Tumours in which inhibition of the EGFR pathway is considered relevant by the Investigator are not mandated but are encouraged.

  5. ECOG performance status ≤2

  6. Life expectancy of ≥12 weeks

  7. BMI 18-35.

  8. Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to dosing if of child-bearing potential or must have evidence of non-child bearing potential

  9. Males should use barrier contraception until 6 months after the last study drug is taken.

Critères de non-inclusion :
  1. Participation in another clinical study with an IP during the last 14 days (or a longer period, depending on the agents used).

  2. Treatment with any of the following:

    Patients with severe renal impairment only: use of concurrent medication known to affect CrCl within 7 days of the first dose

    • Treatment with a 1st or 2nd generation EGFR-TKI within 8 days or approximately 5 half-lives, prior to the first dose of study drug.
    • Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 14 days of the first dose of study drug.
    • Osimertinib in the present study or has previously received a 3rd generation EGFR-TKI (eg, CO 1686).
    • Major surgery within 4 weeks of the first dose of study drug.
    • Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment
    • Currently receiving medications or herbal supplements known to be potent inducers of CYP3A4. Patients in Part B and continued access must avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer effects on CYP3A4.
  3. Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment; with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy

  4. Spinal cord compression or brain metastases, unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment

  5. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:

    • Absolute neutrophil count <1.5 x 109/L
    • Platelet count <100 x 109/L
    • Haemoglobin <90 g/L
    • ALT >2.5 times the ULN if no demonstrable liver metastases or >5xULN in the presence of liver metastases
    • AST >2.5xULN if no demonstrable liver metastases or > 5xULN in the presence of liver metastases
    • Total bilirubin >1.5 times ULN if no liver metastases or >3xULN in the presence of liver metastases
  6. Any of the following cardiac criteria:

    Unable to swallow oral medication or patients with GI disorders or significant GI resection.

    • Mean resting QT interval QTcF >470 msec, obtained from 3 ECGs.
    • Abnormalities in rhythm, conduction or morphology of resting ECG
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
  7. Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.

  8. Severe portal hypertension or surgical porto-systemic shunts.

  9. Kidney transplant

  10. On dialysis

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest SENELLART Helene - - / Oui 11/05/2018
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