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351 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : " COMBO D5330C00004"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase Ia, Phase Ib
Descriptif

Experimental: Module 1 Part A
Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 1 Part B
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 2 Part A1
Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Intervention: Drug: Administration of AZD6738

Experimental: Module 2 Part A2
Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B1
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B2
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B3
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B4
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 3 Part A
Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Experimental: Module 3 Part B
Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Informations

ATM deficient, ATM proficient, HER2 negative, Breast, Gastric, Head & Neck, Lung

cancer métastatique

ligne de traitement variable selon les organes

 

12/12/2018
B3 : cancer du sein HER2 négatif avec mutation BRCA1 ou BRCA2 somatique ou germinale, en 2ème et 3ème ligne : Fermé
B4 : cancer du sein triple négatif sans mutation BRCA1 ou BRAC2 identifiée, en 2ème ou 3ème ligne : Ouvert

 

Phase: 1,1b,

Promoteur: AstraZeneca
Autre(s) acronyme(s): D5330C00004
Contact promoteur: AstraZeneca Clinical Study Information Center
AstraZeneca Cancer Study Locator Service

-
Source: Clinical trials.gov le 02/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies

Critères d'inclusion :
  1. "Aged at least 18

  2. The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

  3. Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

  4. Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.

  5. Module 2 Part B All - No previous treatment with PARP inhibitor.

  6. Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

  7. Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

  8. Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer

  9. Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma"

Critères de non-inclusion :
  1. "A diagnosis of ataxia telangiectasia

  2. Prior exposure to an ATR inhibitor

  3. Bad reaction to AZD6738

  4. Module 1: Contra-indicated for treatment with carboplatin

  5. Module 2: Contra-indicated for treatment with olaparib

  6. Module 3: Contra-indicated for treatment with MEDI4736"

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 Dr CAMPONE Mario - - / Oui 11/09/2018
Afficher les détails
Acronyme : "2017-A02058-45 PHRC-K16-164 STEREOPOSTOP"
Spécialité : ORL
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Intervention: Radiation: postoperative hypofractionated stereotactic radiotherapy

Informations

Carcinome épidermoide, stade 1, stade 2

Oropharynx, cavité buccale

Adjuvant

Phase: 2

Promoteur: Centre Jean Perrin
Autre(s) acronyme(s): PHRC-K16-164
STEREOPOSTOP
Contact promoteur: Julian BIAU
Mail promoteur: julian.biau@clermont.unicancer.fr
Tel promoteur: 33473278089

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins

Critères d'inclusion :
  1. Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx

  2. pT1 or pT2 ((UICC 7th edition 2009)

  3. Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

    positive R1 margin (re-resection not proposed)

    close margin < 5 mm (re-resection not proposed)

    Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)

  4. N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)

  5. Age ≥ 18 years

  6. ECOG status ≤ 2

  7. Written signed informed consent before any specific procedure of the protocol

  8. Affiliation to a social security scheme or beneficiary of such a scheme

Critères de non-inclusion :
  1. Other histology than squamous cell carcinoma

  2. pT3 or pT4

  3. pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board

  4. Lymphovascular invasion justifying neck irradiation

  5. Neck irradiation decided in multidisciplinary tumor board

  6. Lack of at least one of the following elements :

    pre-operative medical imaging (CT scan or MRI)

    endoscopy report

    surgery report

    pathological report

  7. Prior radiotherapy to the head and neck area

  8. Distant metastasis

  9. Pregnant or nursing (lactating) woman

  10. women or men of childbearing age not taking adequate contraceptive measure

  11. participation in another investigational study within 4 weeks prior to inclusion

  12. History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

  13. Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Chamois - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com NC / NC Oui 21/02/2019
Afficher les détails
Acronyme : "205801 GSK205801 Ombrelle"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Subjects receiving GSK3359609 (ICOS Agonist) + Docetaxel
Subjects will receive the combination once every 3 weeks as an IV infusion. Subjects receiving docetaxel will be premedicated according to approved product label or standard practice.

Drug: Docetaxel
Drug: GSK3359609 (ICOS Agonist)
Active Comparator: Subjects receiving Docetaxel
Subjects will receive docetaxel once in every 3 weeks as an intravenous infusion.

Informations

Cancer du poumon non à petites cellules (CPNPC), avancé ayant progressé à un précédent traitement anti-PD(1) et aux chimiothérapies à base de sel de platine

2ème ligne et +

Phase: 2

Promoteur: GSK
Autre(s) acronyme(s): Ombrelle
Contact promoteur: US GSK Clinical Trials Call Center

Mail promoteur: GSKClinicalSupportHD@gsk.com
Tel promoteur: 877-379-3718



Cet essai dans d'autres annuaires :

Titre :

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

Critères d'inclusion :
  1. Subjects capable of giving signed informed consent/assent.

  2. Male or female, aged 18 years or older at the time consent is obtained.

  3. Subjects with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and: a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease: i. A maximum of 1 line of platinum-containing chemotherapy regimen in the metastatic setting, and ii. A maximum of 1 line of PD(L)1 monoclonal antibody (mAb) containing regimen. b. Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration. Participants with this alteration could have received up to 3 lines of systemic anticancer therapy.

  4. Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.

  5. ECOG PS score of 0 or 1.

  6. A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.

  7. Adequate organ function.

  8. A male subject must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

  9. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply: a) Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

Critères de non-inclusion :
  1. Subjects who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment): a. Docetaxel at any time. b. Any of the investigational agents being tested in the current study, including experimental ICOS agonist. c. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. d. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.

  2. Received >=3 prior lines of therapy for NSCLC, including subjects with BRAF molecular alternations.

  3. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years.

  4. Central nervous system (CNS) metastases, with the following exception: Subjects with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to first dose of study treatment.

  5. Major surgery <= 28 days of first dose of study treatment.

  6. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.

  7. Receiving systemic steroids (>=10 milligram [mg] oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.

  8. Prior allogeneic/autologous bone marrow or solid organ transplantation.

  9. Receipt of any live vaccine within 30 days prior to first dose of study treatment.

  10. Toxicity from previous anticancer treatment that includes: a. >= Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation. b. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).

  11. History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past-pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.

  12. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.

  13. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.

  14. History or evidence of cardiac abnormalities within the 6 months prior to enrollment.

  15. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.

  16. Active infection requiring systemic therapy.

  17. Subjects with known human immunodeficiency virus infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.

  18. Subjects with history of severe hypersensitivity to monoclonal antibodies or hypersensitivity to ingredients used in the formulation of docetaxel.

  19. Subjects requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes.

  20. Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.

  21. Pregnant or lactating female subjects.

  22. Subject is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES CHU Pneumologie Dr BENNOUNA - CORVAISIER Murielle - NC / NC Oui 23/05/2019
Afficher les détails
Acronyme : "2102-HEM-101 FT-2102 Forma FT-2102-HEM-101"
Spécialité : Hématologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: PH1 Dose Escalation & Expansion FT-2102
Intervention: Drug: FT-2102


Experimental: PH1 Esc. and Exp. FT-2102+Azacitidine
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH1 Esc. and Exp. FT-2102+Cytarabine
Interventions:
Drug: FT-2102
Drug: Cytarabine


Experimental: PH2 Cohort 1 FT-2102 Single Agent
At the completion of Phase 1, Phase 2 Cohort 1 will commence enrollment wherein patients with relapsed or refractory (R/R) AML will be treated with the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 2 FT-2102 Single Agent
In Phase 2 Cohort 2, patients with AML/ MDS in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after cytotoxic-containing induction therapy with residual IDH-R132 mutation will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 3 FT-2102 Single Agent
In Phase 2 Cohort 3, patients with R/R AML/MDS, previously treated with an IDH1 inhibitor will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 4 FT-2102+Azacitidine
In Phase 2 Cohort 4, patients with R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 5 FT-2102+Azacitidine
In Phase 2 Cohort 5, patients with R/R AML/MDS that have inadequately responded or have progressed immediately proceeding hypomethylating therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 6 FT-2102+Azacitidine
In Phase 2 Cohort 6, patients with R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine

Informations

Leucémie myéloïde aiguë ou de syndrome myélodysplasique

mutation IDH1

récidivant ou réfractaire

2ème ligne ou +

Phase: 1,2

Promoteur: NR
Acronymes: 2102-HEM-101 FT-2102
Promoteur : Forma FT-2102-HEM-101

Source: Clinical trial.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Critères d'inclusion :
  1. Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.

  2. Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

  3. Good performance status

  4. Good kidney and liver function

Critères de non-inclusion :
  1. Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy

  2. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

  3. Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication

  4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therap

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 Dr Nimubona - - 0 / 0 Oui 29/11/2018
Afficher les détails
Acronyme : "29BRC18-0005 VinMetAtezo NCT03801304"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Atezolizumab associated with vinorelbine

Atezolizumab will be administered with IV infusions. The first one will be a 60-min IV infusion; the subsequent infusions will last 30 minutes when well-tolerated at the dose of 1200 mg on day 1 of each 21-day cycle.
Vinorelbine capsules are taken orally on days 1, 3 and 5 of each week of the 21-day cycle. Vinorelbine will be administered at the dose of 40 mg per day on days 1, 3 and 5 of each week of the 21-day cycle. In case of toxicity, the dose will be decreased to 30 mg.

Informations

Cancer des bronches non à petites cellules (CBNPC)

2ème ligne, récurrent, localement avancé ou métastatique

Phase: 2

Promoteur: University Hospital, Brest
Autre(s) acronyme(s): VinMetAtezo
Contact promoteur: Alain VERGNENEGRE, PUPH
Contact: Sophie LECANUET

Mail promoteur: alain.vergnenegre@unilim.fr
sophie.lecanuet.pro@gmail.com
Tel promoteur: 555056629 ext +33
617987516 ext +33

-
Source: Clinical Trials 2019

Cet essai dans d'autres annuaires :

Titre :

Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

Critères d'inclusion :
  1. Histologically confirmed NSCLC;

  2. Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC);

  3. Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions.

  4. Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable;

  5. Patients must have a measurable lesion (RECIST V1.1);

  6. Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1;

  7. Age ≥18 years, either sex;

  8. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;

  9. Life expectancy exceeds 12 weeks;

  10. No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin;

  11. Adequate organ function, demonstrated by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin <1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase <2.5 × N or <5 × N if liver metastasis is present;

  12. Normal renal function (calculated creatinine clearance ≥45 mL/min);

  13. Normal calcemia;

  14. Normal hematological function (polynuclear neutrophils >1.5 G/L, platelets >100 G/L);

  15. Women of child-bearing potential must use effective contraception;

  16. Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment;

  17. Written informed consent to participate in the study

  18. Patient with social insurance

Critères de non-inclusion :
  1. ECOG PS >2;

  2. Known hypersensitivity to immunotherapy;

  3. Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer;

  4. Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ;

  5. Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug;

  6. Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging;

  7. Medical contraindication to oral vinorelbine;

  8. Persistence of clinical adverse events related to prior treatment;

  9. Active brain metastases (e.g. stable for <4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants; dexamethasone will be allowed if administered at a stable dose <10 mg/day for at least 1 month before randomization);

  10. Concurrent radiotherapy, except for palliative bone irradiation.

  11. Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction <12 months before study entry);

  12. Active or prior documented autoimmune or inflammatory disorders;

  13. Active B hepatitis, HIV infection …;

  14. Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial;

  15. Grade-3 peripheral neuropathy;

  16. Uncontrolled infection;

  17. Interstitial lung disease or pneumonitis requiring steroid management;

  18. Corticosteroid therapy exceeding 10 mg/day;

  19. Other severe organic disorders not allowing inclusion in the trial;

  20. Malabsorption syndrome;

  21. Pregnancy or breast-feeding;

  22. Follow-up not possible; and incarcerated or institutionalized patients.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Lorient - Centre Hospitalier Bretagne Sud Dr. R LAMY - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 10/10/2019
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr 1 / 3 Oui 23/08/2019
Afficher les détails
Acronyme : "7902-005 NCT03797326 2018-003747-37 MK-7902-005 E7080-G000-224 LEAP-005"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Pembrolizumab + Lenvatinib

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Informations

Tumeurs solides métastatiques, incurables, non réséquables

Cancer du sein triple neg, cancer de l'ovaire, Cancer Gastrique, Cancer colorectal, Glioblastome, Cancer des voies biliairs

Lignes variables selon l'organe

2 places par centre 18/09/2019

TNBC - 25 : 5 slot available

Ovarian - 27 : 3 slot available

Gastric - 23 : 7 slot available

GBM - 23 : 7 slot available

Phase: 2

Promoteur: Merck Sharp & Dohme Corp.

Autre(s) acronyme(s): NCT03797326

2018-003747-37
MK-7902-005
E7080-G000-224
LEAP-005
Contact promoteur: Merck Sharp & Dohme Corp.
Mail promoteur: Trialsites@merck.com
Tel promoteur: 1-888-577-8839


Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

Critères d'inclusion :
  1. Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer: non-microsatellite instability-High/proficient mismatch repair (MSI-H/pMMR) tumor, GBM, BTC: intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater

  2. Must have progressed on or since the last treatment

  3. Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR

  4. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

  5. Male participants agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment, and refrain from donating sperm during this period

  6. Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days after the last dose of study treatment

  7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days of study treatment initiation

  8. Has adequate organ function

    For Triple Negative Breast Cancer Participants:

  9. Has received one or 2 prior lines of therapy

  10. Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)

    For Ovarian Cancer Participants:

  11. - Has received 3 prior lines of therapy

    For Gastric Cancer Participants:

  12. - Has received 2 prior lines of therapy

    For Colorectal Cancer Participants:

  13. Has received 2 prior lines of therapy

  14. Has a locally determined non-MSI-H/pMMR tumor

    For GBM Participants:

  15. Has failed initial systemic therapy for newly diagnosed GBM

  16. Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines

  17. Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable

  18. Has histologically confirmed World Health Organization (WHO) Grade IV GBM

    For Biliary Tract Cancer Participants:

  19. Has received 1 prior line of therapy

  20. Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

Critères de non-inclusion :
  1. Has presence of gastrointestinal condition including malabsorption that might affect the absorption of lenvatinib

  2. Radiographic evidence of major blood vessel invasion/infiltration

  3. Clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment

  4. Has significant cardiovascular impairment within 12 months of the first dose of study treatment: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability

  5. Has a history of arterial thromboembolism within 12 months of start of study treatment

  6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

  7. Serious nonhealing wound, ulcer or bone fracture

  8. Biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry.

  9. Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])

  10. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to study treatment start

  11. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment

  12. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease

  13. Has received a live vaccine within 30 days prior to the first dose of study treatment

  14. Known intolerance to study treatment (or any of the excipients)

  15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

  16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

  17. Has known active CNS metastases and/or carcinomatous meningitis

  18. Has tumors involving the brain stem

  19. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

  20. Has an active autoimmune disease that has required systemic treatment in past 2 years

  21. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

  22. Has an active infection requiring systemic therapy

  23. Has a known history of human immunodeficiency virus (HIV) infection

  24. Has a known history of hepatitis B or known active hepatitis C virus infection

  25. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

  26. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

  27. Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

    For Colorectal Cancer Participants:

  28. - Has MSI-H/dMMR disease

  29. For GBM Participants:

  30. Has carcinomatous meningitis

  31. Has recurrent tumor greater than 6 cm in maximum diameter

  32. Has tumor primarily localized to the brainstem or spinal cord

  33. Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease

  34. Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans

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 - PARERE Adèle - NC / NC Oui 23/08/2019
Afficher les détails
Acronyme : "ALBAN UC-0160/1717 NCT03799835 "
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Arm A : control arm
BCG therapy only

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).

Experimental: Arm B: experimental arm
BCG therapy + administration of atezolizumab

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

Informations

Cancer de la vessie non infiltrant haut risque, adjuvant

Phase: 3

Promoteur: UNICANCER
Autre(s) acronyme(s): UC-0160/1717
NCT03799835
Contact promoteur: Soazig Nénan-Le Ficher
Maggy Chausson
Mail promoteur: s-nenan@unicancer.fr
m-chausson@unicancer.fr

Tel promoteur: 33185343113
33185343112 ou 33185343112

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

Critères d'inclusion :
  1. Signed informed consent form

  2. Adult man and women ( age ≥18 years)

  3. Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the Following :

    T1 tumor and/or

    High grade (G3) and/or

    Carcinoma in situ (CIS)

  4. Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1

  5. At least one additional (second) resection of the primary tumor has been performed in case of T1 tumors, or incomplete initial TURB, or in case of doubt about completeness of a TURB, or if there is no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found) without upstaging towards MIBC (EAU guidelines, 2017)

  6. Absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 42 days prior to the first study treatment

  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

  8. Life expectancy ≥12 weeks

  9. Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)

  10. Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment:

    absolute neutrophil count (ANC) ≥1500 cells/μL

    white blood cell (WBC) counts >2500/μL

    Lymphocyte count ≥300/μL

    Platelet count ≥100,000/μL

    Hemoglobin ≥9.0 g/dL

    aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)

    Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.

    Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN

    Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)

  11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab

  12. Patients affiliated to the social security system

  13. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up

Critères de non-inclusion :
  1. Patient having received previous BCG therapy for bladder cancer

  2. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are authorized

  3. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment

  4. Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following:

    Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent and without prostate-specific antigen (PSA) recurrence are eligible.

    Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.

    Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.

  5. Pregnancy or breastfeeding

  6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

  7. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

  8. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases)

    Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.

    Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.

    History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.

    History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

  9. Serum albumin <2.5 g/dL

  10. Known HIV infection

  11. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test at screening) or hepatitis C.

    Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation.

    Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

  12. Known active tuberculosis

  13. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

  14. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

  15. Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.

  16. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.

    - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.

  17. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study

  18. Prior allogeneic stem cell or solid organ transplant

  19. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study

    - Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab).

  20. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

  21. Prior treatment with CD137 agonists or immune checkpoint−blockade therapies, including anti-CD40, anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

  22. Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

  23. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial

    Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study.

    The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.

  24. Person deprived of their liberty or under protective custody or guardianship

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr BESSON/Dr CORBEL - - NC / NC Oui 10/10/2019
Afficher les détails
Acronyme : "ANCHOR-CRC NCT03693170 W00090 GE 2 01 ANCHOR"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: 1 Arm
encorafenib plus binimetinib plus cetuximab

Informations

Cancer colorectal métastatique non traité BRAFV6009 Mutant

1ère ligne

Phase: 2

Promoteur: Pierre Fabre Medicament
Autre(s) acronyme(s): NCT03693170
W00090 GE 2 01
ANCHOR
Contact promoteur: Karim Keddad, MD

Mail promoteur: contact_essais_cliniques@pierre-fabre.com
Tel promoteur: 33534506000
Coordonnateur: Karim Keddad, MD

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Critères d'inclusion :
  1. Male or female ≥ 18 years of age

  2. Histologically or cytologically confirmed CRC that is metastatic

  3. Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory

  4. Evidence of measurable disease as per RECIST, v1.1

  5. Subject able to receive cetuximab as per approved label with regards to RAS status

  6. ECOG Status 0 or 1

  7. Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol

  8. Subject able to take oral medications

Critères de non-inclusion :
  1. Prior systemic therapy for metastatic disease

  2. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors

  3. Symptomatic brain metastasis or Leptomeningeal disease

  4. History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO

  5. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.

  6. Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start

  7. History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment

  8. Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase

  9. Known contraindication to cetuximab administration as per SPC/approved label

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 Pr J. P. Metges - Aurore Cottin - aurore.cottin@chu-brest.fr

02 98 22 32 98

NC / NC Oui 10/09/2019
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 : "BGB-290-303 2017-003493-13"
Spécialité : Digestif
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Intervention: Drug: BGB-290

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Intervention: Drug: Placebo"

Informations

Cancer de l'estomac locallement avancé inopérable ou métastatique

Ayant répondu à une première ligne de platine

maintenance

Phase: 3

Promoteur: BeiGene
Acronymes: BGB-290-303
2017-003493-13
Contact promoteur: Heinrich Farin, MD

Mail promoteur: Clinicaltrials@beigene.com
Tel promoteur: 781-801-1800
Coordonnateur: NR
-
Source: Clinicaltrials.gov du 02/05/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

Critères d'inclusion :
  1. "Age ≥ 18 years.

  2. Signed informed consent.

  3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

  4. Received platinum based first line chemotherapy for ≤ 28 weeks.

  5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

  6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

  7. ECOG performance status ≤ 1.

  8. Adequate hematologic, renal and hepatic function.

  9. Must be able to provide archival tumor tissue for central biomarker assessment.

  10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last "

Critères de non-inclusion :
  1. "Unresolved acute effects of prior therapy ≥ Grade 2.

  2. Prior treatment with PARP inhibitor.

  3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.

  4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

  5. Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.

  6. Other diagnoses of significant malignancy

  7. Leptomeningeal disease or brain metastasis

  8. Inability to swallow capsules or disease affecting gastrointestinal function.

  9. Active infections requiring systemic treatment.

  10. Clinically significant cardiovascular disease

  11. Pregnant or nursing females."

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 Pr J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 10/09/2019
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails

Fiche détaillée de l'essai