Sélectionnez un ou plusieurs critères :
Ou bien effectuez une recherche par mots-clés :
Recherche avancée
Signaler une étude manquante, non à jour ou une erreur
Avertissement : Ces informations sont données à titre indicatif. Veuillez vous reporter aux documents en vigueur fournis par le Promoteur. Toute utilisation d'un schéma thérapeutique non validé est sous la responsabilité du prescripteur.
76 essais correspondent à votre recherche

Fiche détaillée de l'essai

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 Dr J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 02/05/2018
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails
Acronyme : "COMBIAPLUS-mélanome COMBI-Aplus CDRB436F2410"
Spécialité : Dermatologie
Traitement : Chimiothérapie adjuvante
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Dabrafenib and trametinib combination therapy
Subjects will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Informations

Mélanome de stade III - Mutation BRAFV600- Adjuvant

Soins de support

05/03/2019 : nouveau critère d'exclusion : exclure les patients ayant déjà eu un mélanome de stade III

Phase: 3 b

Promoteur: Novartis
Autre(s) acronyme(s): COMBIAPLUS-mélanome COMBI-Aplus
Contact promoteur: Novartis Pharmaceuticals
Mail promoteur: novartis.email@novartis.com


Tel promoteur: 41613241111
81337978748
Coordonnateur: NR
-
Source: Clinical trials 2018

Cet essai dans d'autres annuaires :

Titre :

Open label, phase IIIB study of Dabrafenib in combination with trametinib in the adjuvant treatment of stage III V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adaptated pyrexia AE-management algorythm.

Critères d'inclusion :
  1. Completely resected (R0) histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]

  2. V600E/K mutation positive using a validated local test

  3. Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.

  4. Subjects with an unknown primary melanoma are not eligible.

  5. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Critères de non-inclusion :
  1. Uveal or mucosal melanoma

  2. Evidence of metastatic disease including unresectable in-transit metastasis

  3. Received any prior adjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma

  4. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ

  5. History or current evidence of cardiovascular risk

  6. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy

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 Jacobzone - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 21/05/2019
Rennes - Centre Eugène Marquis Dr Thierry Lesimple - Sophie Gimenez - s.gimenez@rennes.unicancer.fr nc / nc Oui 21/05/2019
Afficher les détails
Acronyme : "CONTESSA ODO-TE-B301 CONTESSA-SEIN"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Arm A: Tesetaxel and Capecitabine
Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle


Active Comparator: Arm B: Capecitabine
Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle

Informations

Cancer du SEIN

Métastasique - Avancé

3ieme ligne et plus

Doit avoir recu

  • Taxane (adjuvant, néoadjuvant)
  • Anthracyclines (néoadjuvant, adjuvant ou métastatique)
  • Hormonothérapie

Ne doit pas avoir recu

  • Pas plus de 1 ligne de chimiothérapie
  • Capécitabine
  • Taxane en métastatique

Phase 3

Promoteur: Odonate Therapeutics, LLC
Acronymes: CONTESSA ODO-TE-B301
CONTESSA-SEIN
Contact promoteur:
Contact: Valerie Legagneur
Contact: Jill Krause

Cet essai dans d'autres annuaires :

Titre :

Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane

Critères d'inclusion :

Amendement N°3 04/10/2018: critère d'inclusion N°5 modifié : ont été retirés :

Patient may have CNS métastases that are stable or progressing radiologically
Patient with current evidence of leptomeningeal disease are not eligible

 

  1. Female or male patients at least 18 years of age
  2. Histologically or cytologically confirmed breast cancer

  3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status.

  4. HR (ER and/or PgR) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status.

  5. Measurable disease per RECIST 1.1 or bone-only disease with lytic component. Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.

  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

  7. Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting

  8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.

  9. Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.

  10. Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.

  11. Adequate hematologic, hepatic, and renal function, as evidenced by:

    Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support

    Platelet count ≥ 100,000/μL

    Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support

    Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome

    Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

    Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

    Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN

    Calculated creatinine clearance ≥ 50 mL/min

    Serum albumin ≥ 3.0 g/dL

    Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulant

  12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy

  13. Ability to swallow an oral solid-dosage form of medication

  14. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)

  15. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of Study treatment

    • Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm

  16. Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 130 days after last dose of Study treatment

    • Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success.

  17. Written informed consent and authorization to use and disclose health information

  18. Ability to comprehend and comply with the requirements of the Stud

Critères de non-inclusion :

Amendement N°3 04/10/2018
Modification du critère d'exclusion N°4 : is revised to only exclude patients with know leptomeningeal desease
Modification du critère d'exclusio N°11 : is revised to allow for treatment with stereotactic brain radiosurgery within <14 days prior to the date of randomisation.

  1. Two or more prior chemotherapy regimens for advanced disease
  2. Prior treatment with a taxane in the metastatic setting

  3. Prior treatment with capecitabine

  4. Known metastases to the central nervous system

  5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study

  6. Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.

  7. Active hepatitis B or active hepatitis C infection

  8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study.

  9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0

  10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this Study

  11. Anticancer treatment, including endocrine therapy, radiotherapy, chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of Randomization

  12. Major surgery ≤ 28 days prior to the date of Randomization; patient must have complete recovery from surgery

  13. Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways)

  14. History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents, or any of their ingredients

  15. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.

  16. Pregnant or breastfeeding

  17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study

  18. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of Randomization

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 Véronique DIERAS - v.dieras@rennes.unicancer.fr Perrette Quéric - p.queric@rennes.unicancer.fr / Oui 24/08/2018
Afficher les détails
Acronyme : "DS8201-A-U301 DESTINY-Breast02 NCT03523585 2018-000221-31 ( EudraCT Number ) 184017 ( Registry Identifier: JAPIC CTI )"
Spécialité : Gynécologie - Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Trastuzumab deruxtecan (DS-8201a)
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Intervention: Drug: Trastuzumab deruxtecan
Active Comparator: Trastuzumab+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine

Active Comparator: Lapatinib+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Informations

Phase: 3

Promoteur: Daiichi Sankyo, Inc
Autre(s) acronyme(s): DESTINY-Breast02
NCT03523585
2018-000221-31 ( EudraCT Number )
184017 ( Registry Identifier: JAPIC CTI )
Contact promoteur: Daichi
Mail promoteur: dsclinicaltrial@daiichisankyo.co.jp
Tel promoteur: 81-3-6225-1111

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies,

Critères d'inclusion :
  1. Is the age of majority in their country

    Has pathologically documented breast cancer that:

    is unresectable or metastatic

    has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory

  2. was previously treated with ado-trastuzumab emtansine (T-DM1)

  3. Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)

  4. Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.

  5. Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:

    5 months after the last dose of DS-8201a

    6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)

    7 months after the last dose of trastuzumab/capecitabine

  6. Has adequate hematopoietic, renal and hepatic functions

Critères de non-inclusion :
  1. Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo

  2. Has had prior treatment with capecitabine

  3. Has uncontrolled or significant cardiovascular disease

  4. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening

  5. Has active central nervous system (CNS) metastases

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - - NC / NC Oui 18/06/2019
Rennes - Centre Eugène Marquis Dr C. Perrin - - NC / NC À venir 18/06/2019
Afficher les détails
Acronyme : "DS8201-A-U302 DESTINY-Breast03 2018-000222-61 ( EudraCT Number ) 183976 ( Registry Identifier: JAPIC CTI )"
Spécialité : Gynécologie - Sénologie
Traitement : Métastatique 2eme ligne
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Trastuzumab deruxtecan (DS-8201a)
HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with DS-8201a

Active Comparator: Ado-trastuzumab emtansine (T-DM1)
HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with T-DM1
Intervention: Drug: Ado-trastuzumab emtansine (T-DM1)

Informations

Cancer du sein, HER2- positif, non résécable et/ou métastatique

2ème ligne 

 

Phase: 3

Promoteur: Daiichi Sankyo, Inc
Autre(s) acronyme(s): DESTINY-Breast03
2018-000222-61 ( EudraCT Number )
183976 ( Registry Identifier: JAPIC CTI )
Contact promoteur: Daichi
Mail promoteur: dsclinicaltrial@daiichisankyo.co.jp

 

Tel promoteur: 81-3-6225-1111

Source: Clinical Trial 2019"

 

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Critères d'inclusion :
  1. Is the age of majority in their country

  2. Has pathologically documented breast cancer that:

    is unresectable or metastatic

    has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory

    was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane

  3. Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)

  4. Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.

  5. If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of T-DM1

  6. Has adequate renal and hepatic function

Critères de non-inclusion :
  1. Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)

  2. Has uncontrolled or significant cardiovascular disease

  3. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

  4. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.

    Participants with clinically inactive brain metastases may be included in the study.

    Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - - NC / NC Oui 13/06/2019
NANTES - Institut de Cancérologie de l' Ouest FRENEL Jean Sébastien - - NC / NC Oui 13/06/2019
Rennes - Centre Eugène Marquis Dr C. Perrin - Sophie Gimenez - s.gimenez@rennes.unicancer.fr NC / NC Oui 06/06/2019
Afficher les détails
Acronyme : "DS8201-A-U303 DESTINY-Breast04 2018-003069-33 ( EudraCT Number ) 184223 ( Registry Identifier: JAPIC CTI ) NCT03734029"
Spécialité : Gynécologie - Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: DS-8201a
DS-8201a is administered as an intravenous (IV) infusion every 21 days (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes thereafter.
Intervention: Drug: Trastuzumab deruxtecan (DS-8201a)
Active Comparator: Physician's Choice
Physician's choice comparative therapy will be administered in accordance with the locally approved label. The physician's choice is predefined, prior to randomization, from the following options:

Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel
Interventions:
Drug: Capecitabine
Drug: Eribulin
Drug: Gemcitabine
Drug: Paclitaxel
Drug: Nab-paclitaxe

Informations

Cancer du sein HER low (1+, 2+/ISH-), inopérable, métastatique

2ème ou 3ème ligne

Phase: 3

Promoteur: Daiichi Sankyo, Inc
Autre(s) acronyme(s): DESTINY-Breast04
2018-003069-33 ( EudraCT Number )
184223 ( Registry Identifier: JAPIC CTI )
Contact promoteur:
Daichi
Mail promoteur: dsclinicaltrial@daiichisankyo.co.jp
Tel promoteur: 81-3-6225-1111

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Critères d'inclusion :
  1. Is the age of majority in their country

  2. Has pathologically documented breast cancer that:

    Is unresectable or metastatic

    Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)

    Is HR-positive or HR-negative

    Has progressed on, and would no longer benefit from, endocrine therapy

    Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting

  3. Has documented radiologic progression (during or after most recent treatment)

  4. Has adequate tumor samples available or is wiling to provide fresh biopsies prior to randomization for:

    assessment of HER2 status

    assessment of post-treatment status

  5. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

  6. Has at least 1 protocol-defined measurable lesion

  7. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions

  8. If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels

Critères de non-inclusion :
  1. Is ineligible for all options in the physician's choice arm

  2. Has breast cancer ever assessed with high-HER2 expression

  3. Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate

  4. Has uncontrolled or significant cardiovascular disease

  5. Has spinal cord compression or clinically active central nervous system metastases

  6. Has history, current, or suspicion of interstitial lung disease/pneumonitis

  7. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

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 FRENEL Jean Sébastien - - NC / NC À venir 14/06/2019
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - - NC / NC Oui 14/06/2019
Rennes - Centre Eugène Marquis Dr Claudia Lefeuvre - - NC / NC À venir 14/06/2019
Afficher les détails
Acronyme : "DUTRENEO MEDI4736 NEMIO-Vessie"
Spécialité : Urologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Active Comparator: Cisplatin-based neoadjuvant chemotherapy
Patients allocated to the control arm will receive any of the following cisplatin based neoadjuvant treatment:
Regimen 1: Gemcitabine + Cisplatin Regimen 2: Methotrexate + Vinblastine + Doxorubicin + Cisplatin Regimen 3: Gemcitabine + Paclitaxel + Cisplatin
Intervention: Drug: Cisplatin-based neoadjuvant chemotherapy

Experimental: Durvalumab plus Tremelimumab
Patients randomized to experimental arma will receive 28-day treatment cycle x 3 cycles of Durvalumab + Tremelimumab 75 mg every 4 weeks
Interventions:
Drug: Durvalumab
Drug: Tremelimuma"

Informations

Cancer de l'urothélium:  vessie,  uretère, urètre, pelvis rénal

Néoadjuvant

Phase: 2

Promoteur: Fundacion CRIS de Investigación para Vencer el Cáncer
Autre(s) acronyme(s): DUTRENEO MEDI4736
NEMIO-Vessie
Contact promoteur: Ana Moreno

Mail promoteur: ana.moreno@apices.es
Tel promoteur: 34918166804
Coordonnateur: NR
-
Source: Clinical trials.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Prospective Study to Individualize the Approach With DUrvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients.

Critères d'inclusion :
  1. "Male and female subjects; age ≥ 18 years at the time of study entry.

  2. Subjects must provide written informed consent prior to performance of any protocol-related procedures, including screening evaluations and must be willing to comply with treatment and follow up.

  3. Histollogically confirmed MIUC (also termed TTC) of the  bladder. Patients with mixed histologies are required to have a dominant transitional cell pattern (urothélial carcinoma must be > 50 %).

  4. Patients must have confirmed cT2-T4 N0-1 M0 (TNM classification).

  5. Archival tumour samples for biomarker research in formalin-fixed and paraffin-embedded blocks.

  6. Body weight >30kg

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

  8. Life expectancy of at least 12 weeks

  9. Adequate organ function as determined by:

    a) Hematological (without growth factor or transfusion support within 28 days prior to first dose of investigational product)

    Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).

    Platelets ≥ 100,000/mm3 (≥ 100 GI/L)

    Hemoglobin ≥ 9 g/dL (≥ 90 g/L)

  10. Hepatic:

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN.

    Total bilirubin ≤ 1.5 × the upper limit of normal. For subjects with Gilbert's disease ≤ 3 mg/dL (≤ 51.3 μmol/L).

  11. Renal:

    a) Calculated CrCl or 24-hour urine CrCl>40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance

  12. Fasting serum triglycerides ≤ 2.5 × upper limit of normal AND total cholesterol ≤ 300 mg/dL (≤ 7.75 mmol/L). Lipid-lowering medication is allowed.

  13. HbA1c ≤ 8%.

  14. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause."

Critères de non-inclusion :
  1. "Histology of pure adenocarcinoma, pure squamous cell carcinoma, or predominant small cell carcinoma or sarcomatoid features in the tumor sample.

  2. Evidence of any metastatic lesion outside the primary tumour site identified in the radiological evaluation.

  3. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:

    Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection).

    Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent.

    Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).

  4. Previous therapy with PD-1, PD-L1 or CTLA-4 inhibitors, including durvalumab and tremelimumab.

  5. Any concurrent chemotherapy, immunotherapy (IMT), or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.

  6. History of severe allergic reactions (ie, Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.

  7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:

    Patients with vitiligo or alopecia

    Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement

    Any chronic skin condition that does not require systemic therapy

    Patients without active disease in the last 5 years may be included but only after consultation with the study physician

    Patients with celiac disease controlled by diet alone

  8. Major surgery within 4 weeks of study randomization.

  9. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.

  10. Prior radiation therapy to >25% of the bone marrow.

  11. Current treatment on another clinical trial.

  12. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.

  13. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.

  14. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms (ECGs).

  15. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

    Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

    Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.

  16. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)

  17. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).

  18. History of active primary immunodeficiency

  19. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV Ribonucleic acid (RNA).

  20. Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or C or active hepatitis A.

  21. Receipt of live, attenuated vaccine within 30 days prior to the first dose of investigational products.

  22. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.

  23. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

  24. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

  25. History of leptomeningeal carcinomatosis"

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 Brigitte Laguerre - VALAT Sarah - NC / NC Oui 11/12/2018
Afficher les détails
Acronyme : "H3B-6527 H3B-6527-G000-101 2016-001915-19 ( EudraCT Number ) NCT02834780"
Spécialité : Hépatologie - Voies biliaires
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: H3B-6527 (escalation and expansion)
Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Intervention: Drug: H3B-6527

Informations

Carcinome hépatocellulaire ou cholangiocarcinome intrahépatique, avancé,

2ème ligne et +

1ère ligne (si traitement standard contre indiqué)

Phase: 1

Promoteur: H3 Biomedicine Inc
Autre(s) acronyme(s): H3B-6527-G000-101
2016-001915-19 ( EudraCT Number )
NCT02834780
Contact promoteur: Contact: Eisai Medical Information

Mail promoteur: esi_oncmedinfo@eisai.com
Tel promoteur: 1-888-274-2378

Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

Critères d'inclusion :
  1. Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).

  2. Must have received at least one prior standard-of-care therapy or declined such therapy.

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2 only).

  5. Adequate bone marrow and organ function.

Critères de non-inclusion :
  1. Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV).

  2. Known human immunodeficiency virus (HIV) infection.

  3. Presence of gastric or esophageal varices requiring active treatment.

  4. Previous treatment with selective FGF19-FGFR4 targeted therapy.

  5. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.

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 Julien Edeline - Christelle NICOLLE - c.nicolle@rennes.unicancer.fr NC / NC Oui 28/06/2019
Afficher les détails
Acronyme : "IMpassion132 MO39193 2016-005119-42"
Spécialité : Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

" Experimental: Atezolizumab (gemcitabine, capecitabine, carboplatin)
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle

Placebo Comparator: Placebo
Participants will receive Placebo on day 1 of each 3-week treatment cycle (gemcitabine, capecitabine, carboplatine)
"

Informations

Cancer du sein triple négatif

Locallement avancé, métastatique ou récidive

ayant recu anthracyclines et taxanes

Phase: 3

Promoteur: Hoffmann-La Roche
Acronymes: IMpassion132 MO39193
2016-005119-42
Contact promoteur: Study Director:
Reference Study ID Number: MO39193
Mail promoteur: global-roche-genentech-trials@gene.com
Tel promoteur: 888-662-6728 (U.S. and Canada)
Coordonnateur: NR
-
Source: clinicaltrials.org
24/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

Critères d'inclusion :
  1. "Inclusion Criteria:

  2. Histologically confirmed triple negative breast cancer(TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic

  3. Documented disease progression occurring within 12 months from the last treatment with curative intent

  4. Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted

  5. Measurable or non-measurable disease, as defined by RECIST 1.1

  6. Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 25 unstained slides with an associated pathology report, if available

  7. Eastern Cooperative Oncology Group performance status 0-1

  8. Life expectancy ≥ 12 weeks

  9. Adequate haematologic and end-organ function

  10. Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening

  11. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening

  12. The HBV DNA test will be performed only for patients who have a positive HBcAb test

  13. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.

  14. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of study treatment

  15. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm"

Critères de non-inclusion :
  1. "Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation

  2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

  3. Symptomatic or rapid visceral progression

  4. No prior treatment with an anthracycline and taxane

  5. History of leptomeningeal disease

  6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)

  7. Uncontrolled tumour-related pain

  8. Uncontrolled or symptomatic hypercalcemia

  9. Malignancies other than TNBC within 5 years prior to randomisation)

  10. Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina

  11. Presence of an abnormal ECG

  12. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.

  13. Current treatment with anti-viral therapy for HBV.

  14. Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis

  15. Treatment with investigational therapy within 28 days prior to randomisation

  16. Pregnant or lactating, or intending to become pregnant during or within 5 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 Véronique DIERAS - v.dieras@rennes.unicancer.fr Lucile MORVAN - / Oui 27/08/2018
Afficher les détails
Acronyme : "IPH2201203-VADS IPH2201-203 NCT02643550"
Spécialité : ORL
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: Dose escalation
Dose escalation of monalizumab in combination with cetuximab

Experimental: Expansion cohort 1
monalizumab + cetuximab expansion cohort


Experimental: Expansion cohort 2
monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers

Experimental: Expansion cohort 3
monalizumab + cetuximab + anti-PD(L)1

Informations

Cancer du nasopharynx , de l'oropharynx, de l'hypopharynx, du larynx (supraglottis, glottis, sous glottis) ou de la cavité buccale, récurrent ou métastatique

lignes selon cohortes

Phase: 1-2

Promoteur: Innate Pharma
Autre(s) acronyme(s): IPH2201-203
Contact promoteur: Agnes Boyer Chammard, MD
Franceline Calmels

Mail promoteur: Agnes.BOYER-CHAMMARD@innate-pharma.fr
Franceline.CALMELS@innate-pharma.fr
Tel promoteur: 33430303120
33430303062

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Critères d'inclusion :
  1. Age ≥ 18 years

  2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity,

  3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or physical examination with measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1


For phase II cohorts:

Cohort #1: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent
Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent,who have received a maximum of two prior systemic regimens in the R/M setting and who have received prior PD-(L)1 blockers
Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in the R/M setting and who have not received prior PD-(L)1 inhibitors

Critères de non-inclusion :
  1. For phase II cohort #1 and cohort #2: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).

  2. For phase II cohort #1 and cohort #2 : Patients who received cetuximab or another inhibitor of epidermal growth factor receptor are excluded from the phase II of the trial, except if cetuximab was given as part of a primary treatment approach, with no progressive disease for at least 4 months following the end of prior cetuximab treatment.

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 ROLLAND Frederic - - NC / nc Oui 19/06/2019
Rennes - Centre Eugène Marquis Dr E. Vauléon - Lucie LANGLOIS - NC / NC Oui 19/06/2019
Afficher les détails

Fiche détaillée de l'essai