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32 essais correspondent à votre recherche

Fiche détaillée de l'essai

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 : "PANIRINOX UCGI 28 PANIRINOX 2016-001490-33 "
Spécialité : Digestif
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: A=Experimental group
FOLFIRINOX + Panitumumab oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² given as a 2-hour IV infusion with the addition, after 30 minutes of irinotecan 150mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion.


Active Comparator: B=Control group
mFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² IV infusion over 2 hours followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400mg/m² over 46 hours continuous infusion.

Informations

Cancer colorectal métastatique

(K-RAS, N-RAS, B-RAF sauvage déjà déterminés)

1ère ligne métastatique (exclus: patient ayant recu de l'oxaliplatin en adjuvant)

"Phase: 2

Promoteur: Unicancer
Acronymes: PANIRINOX
UCGI 28 PANIRINOX
2016-001490-33
Contact promoteur: Sandra PELISSIER

Mail promoteur: s-pelissier@unicancer.fr
Tel promoteur: 33 1 44 23 55 68
-
Source: https://clinicaltrials.org 19/10/17

Cet essai dans d'autres annuaires :

Titre :

Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

Critères d'inclusion :
  1. Age between 18 and 75 years

  2. ECOG PS between 0 and 1

  3. Histologically confirmed adenocarcinoma of the colon or rectum

  4. Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent

  5. K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology

  6. Measurable disease according to RECIST version 1.1

  7. Adequate hematologic, hepatic and renal functions:

    Absolute neutrophil count (ANC) ≥2 x 109/L

    Haemoglobin ≥9 g/dL

    Platelets (PTL) ≥100 x 109/L

    AST/ALT ≤5 x ULN

    Alkaline phosphatase ≤2.5 x ULN

    Bilirubin ≤1.5 x ULN

    Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)

  8. Life expectancy of at least 3 months

  9. Adequate contraception if applicable

  10. Patient affiliated to a social security regimen

  11. Patient information and signed written consent form

Critères de non-inclusion :
  1. History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)

  2. Adjuvant treatment with oxaliplatin

  3. Previous treatment for metastatic disease

  4. Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test

  5. Brain metastases

  6. Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study

  7. Patient with history of pulmonary fibrosis or interstitial pneumonitis

  8. Previous organ transplantation, HIV or other immunodeficiency syndromes

  9. Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)

  10. Persistent peripheral neuropathy >grade1 (NCI CT v4.03)

  11. Ionic disorders as:

    Kalemia ≤1 x ULN

    Magnesemia <0.5mmol/L

    Calcemia <2mmol/L

  12. Patient with known dihydropyrimidine dehydrogenase deficiency

  13. QT/QTc>450msec for men and >470msec for women

  14. Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)

  15. Concomitant intake of St. John's wort

  16. Other concomitant cancer

  17. Patient participating another clinical trial

  18. Pregnant woman or lactating woman

  19. Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule

  20. Legal incapacity or limited legal capacity

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Martin-Barbeau - Aude Vincent - a.vincent@bec22.fr / Oui 18/06/2018
Afficher les détails
Acronyme : "TRITON2 CO-338-052 "
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Rucaparib

Oral rucaparib (monotherapy)

Informations
Cancer de la prostate / Adenocarcinome ou carcinome peu différencié 
 
2ieme ligne métastatique après une 1ère ligne de chimiothérapie à base de Taxane"
 
Progression après castration hormonale ou chirurgicale

(BRCA1/2+ ou ATM +)
 
Amendement le 05/1/2018
La cohorte B (non mesurable) est suspendue aux inclusions
 
Amendement le 02/08/2018
Le critère d'inclusion 5 a été scindé en 2 critères pour mieux distinguer l'exigence d'une progressionde la maladie des exigences relatives aux traitements antérieurs. Ceux-ci sont devenus les critères 5 et 6 et la numérotation des critères d'inclusion  été ajustée.[
 
"Phase: 2

Promoteur: Clovis Oncology, Inc.
Acronymes: TRITON2
CO-338-052 
Contact promoteur: Clovis Oncology Clinical Trial Navigation Service

Mail promoteur: clovistrials@emergingmed.com
Tel promoteur: 1-303-625-5160 (ex-USA)
Coordonnateur: NR
-
Source: https://clinicaltrials.gov/ct2/show/NCT02952534?term=triton+2&cond=Prostate+Cancer&rank=1"

Cet essai dans d'autres annuaires :

Titre :

A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

Critères d'inclusion :
  1. Be 18 years old at the time the informed consent form is signed

  2. Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate

  3. Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)

  4. Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease

  5. Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

 

Critères de non-inclusion :
  1. Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer

  2. Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy

  3. Symptomatic and/or untreated central nervous system metastases

  4. Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

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 - Enora Lejeune - / Oui 29/01/2018
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr / Oui 19/03/2018
Afficher les détails
Acronyme : 16338 I3Y-MC-JPCF 2016-004362-26NSABP B-58 Monarche
Spécialité : Sénologie
Traitement : Thérapie ciblée adjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
Interventions:
Drug: Abemaciclib
Drug: Standard Adjuvant Endocrine Therapy

Standard Adjuvant Endocrine Therapy
Standard adjuvant endocrine therapy administered according to package label.
Intervention: Drug: Standard Adjuvant Endocrine Therapy

Informations

Cancer du sein avec atteinte nodulaire / Early stage

HR + HER 2 négatif

traitement adjuvant

Amendement le 09/10/2018 : Clarifications

 

Promoteur: Eli Lilly and Company
Acronymes: MONARCHE
16338
I3Y-MC-JPCF
2016-004362-26
Contact promoteur: Eli Lilly and Company
Mail promoteur: ClinicalTrials.gov@lilly.com

Tel promoteur: 1-877-285-4559 or 1-317-615-4559
-
Source: https://clinicaltrials.gov/ct2/show/NCT03155997?term=MONARCHE&rank=1"

Cet essai dans d'autres annuaires :

Titre :

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Critères d'inclusion :
  1. The participant is ≥18 years of age (or per local regulations).

  2. The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases. 

  3. The participant must have undergone definitive surgical treatment for the current malignancy. 

  4. The participant must have tumor tissue for biomarker analysis available prior to randomization.

  5. The participant must have axillary lymph node involvement by tumor and have one of the following indicating a higher risk of relapse: 

    4 or more axillary lymph nodes involved with cancer
    Tumor size of at least 5 centimeters
    Grade 3 histology
    Ki67 index by central analysis of ≥20% (for study cohort 2)
  6. The participant must be randomized within 12 weeks of completion of last non-endocrine treatment.

  7. If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 8 weeks prior to randomization. AMDT 10/2018 : traitement anti-hormonal en situation adjuvante et utilisation d'analogues de GNRH clarifiés

  8. Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery. 

  9. Women regardless of menopausal status. 

  10. Women of reproductive potential must have a negative serum pregnancy test and agree to use highly effective contraceptive methods.

  11. The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

  12. The participant has adequate organ function.

  13. The participant is able to swallow oral medications.

Critères de non-inclusion :
  1. Stage IV (M1) disease (American Joint Committee on Cancer [AJCC] TNM Staging System for breast cancer - 7th edition).

  2. Stage IA disease (AJCC TNM Staging System for breast cancer - 7th edition).

  3. The participant has a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years.

  4. Females who are pregnant or lactating.

  5. The participant has previously received treatment with any CDK4 and CDK6 inhibitor.

  6. The participant is receiving concurrent exogenous hormone therapy (for example, birth control pills or hormone replacement therapy).

  7. The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).

  8. The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.

  9. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest.

  10. The participant has active bacterial infection, fungal infection, or detectable viral infection.

  11. The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

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 Fanny Le Du - Aurélie Sauvanet - a.sauvanet@rennes.unicancer.fr 17 / Non 19/02/2019
Brest - CHU de Brest - Site Morvan Dr DEIANA Laura - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr / Oui 28/11/2017
Plérin - CARIO - HPCA Dr Martin-Barbeau - Aude Vincent - a.vincent@bec22.fr / Oui 19/03/2018
Afficher les détails
Acronyme : ASPIK Prodige 50 - Prodige-50
Spécialité : Digestif
Traitement : Entretien
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

1/ screening des patients opérés d’un adénocarcinome du côlon stade III ou II à haut risque (cf infra) ET non consommateur d’aspirine en préopératoire (critères cf infra) :
consentement pour l’étude moléculaire de la tumeur colique

2/ Après signature d’un consentement spécifique : Recherche d’une mutation de PI3K sur exon 9 ou 20 dans l’une des 28 plateformes labellisées.

3/ Pour les patients présentant la mutation PI3K, proposition d’inclusion dans l’étude thérapeutique (consentement) une randomisation sera réalisée selon un ratio 1/1 :, aspirine 100 mg/j (1 comprimé) versus placebo (1 comprimé) par jour pendant 3 ans. Le traitement doit débuter dans les 60 jours post-opératoires

Informations

Adénocarcinome du colon stade III ou stade II

à fort risque de récidive - Mutation PIK3 (laboratoire centralisé)

Maintenance

Phase: 3

Promoteur: Fédération Francophone de Cancérologie Digestive (FFCD)
Autre(s) acronyme(s): Prodige 50 - Prodige-50
Contact promoteur: , France
Jérémie BEZ

Tel promoteur: tel : + 33 (0)3 80 39 34 83
fax : + 33 (0)3 80 38 18 41
Coordonnateur: Pr. P. Michel, CHU Rouen

Mail coordonnateur: ( pierre.michel@chu-rouen.fr )
-
Source: FFCD Site 19/12/2016
http://www.ffcd.fr/index.php/essais-therapeutiques/colon/36-essais-therapeutiques/colon/369-prodige-50-aspik

Cet essai dans d'autres annuaires :

Titre :

Etude prospective randomisée en double aveugle aspirine versus placebo chez les patients opérés d’un adénocarcinome du colon stade III ou II à haut risque de récidive avec mutation PI3K. Etude française ASPIK. PRODIGE 50.

Critères d'inclusion :
  1. Age > 18 ans

  2. Adénocarcinome du côlon de stade III

  3. Adénocarcinome Stade II à haut risque MSS

  4. T4bN0 or T4aN0 tumeur pénétrant la surface du péritoine viscéral

  5. ou moins de 12 ganglions examinés

  6. ou au moins deux des critères suivants : envahissement lymphatique, invasion périnerveuse, invasion veineuse ; ou diagnostic sur syndrome occlusif ou sur une perforation ; ou tumeur peu différenciée).

  7. mutation PI3K, exon 9 ou 20 (tumeur)

  8. Résection R0

  9. OMS 0-2

  10. Tomodensitométrie thoracique et abdominale datant de moins de 8 semaines.

  11. Espérance de vie > 3 an

  12. Consentement écrit signé

Critères de non-inclusion :
  1. Traitement anticoagulants et/ou anti agrégants

  2. Consommation d’aspirine régulière (plus de 3 prises par semaine pendant au moins 3 mois pendant la dernière année)

  3. Contre-indication à l’aspirine : Allergie à l ‘aspirine, Antécédent d’ulcère gastroduodénal

  4. Insuffisance hépatique ou rénale sévère

  5. Femme enceinte ou allaitante

  6. Cancer du rectum

  7. Forme héréditaire (i.e. syndrome de Lynch)

  8. Suivi impossible

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Quimper - CHI Cornouaille Dr BIDEAU - Pascaline Rameau - p.rameau@ch-cornouaille.fr 1 / NC Oui 03/01/2019
Saint Malo - Clinique de la Côte d'Émeraude Dr Raoul - - 1 / nc Oui 07/02/2019
Morlaix - Centre Hospitalier des Pays de Morlaix Dr Ferec - mferec@ch-morlaix.fr - 0 / nc Oui 03/01/2019
Plérin - CARIO - HPCA Dr Pierre-Luc ETIENNE - - / À venir 23/02/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Astrid Lièvre - UIC - 1 / 7 Oui 25/02/2019
Saint Malo - Centre Hospitalier de Saint Malo Dr Desgrippes - Stéphane Natur - Stephane.natur@ch-stmalo.fr 0 / 10 Oui 16/05/2019
Afficher les détails
Acronyme : ATLAS CR106935 56021927PCR3003
Spécialité : Urologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Prostatic Neoplasms


Drug: JNJ-56021927
Drug: Bicalutamide
Drug: Bicalutamide Placebo
Drug: JNJ-56021927 Placebo
Drug: GnRH (agonist)
Radiation: 74-80 Grays (units of radiation)

Informations

Phase: 3

Promoteur: Aragon Pharmaceuticals, Inc.

Autre(s) acronyme(s): CR106935, 56021927PCR3003
Contact promoteur: NR
Coordonnateur: Aragon Pharmaceuticals, Inc. Clinical Trial
Mail coordonnateur: JNJ.CT@sylogent.com
Tel Coordonnateur: NR
-
Source: https://clinicaltrials.gov/ct2/show/record/NCT02531516?term=atlas&rank=11

Cet essai dans d'autres annuaires :

Titre :

ATLAS: Étude de phase 3, randomisée, en double aveugle, contrôlée contre placebo, évaluant le JNJ-56021927 chez des patients atteints d'un cancer de la prostate localisé ou localement avancé à haut risque et recevant une radiothérapie en traitement primaire

Critères d'inclusion :
  1. •Age >= 18 years

  2. •Indicated and planned to receive primary radiation therapy for prostate cancer

  3. •Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c

  4. •Charlson index (CCI) <=3

  5. •An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1

  6. •Adequate liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * upper limit of normal (ULN) and total bilirubin <1.5 * ULN

  7. •Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial

  8. •Signed, written, informed consent

  9. •Be able to swallow whole study drug tablets

Critères de non-inclusion :
  1. •Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis

  2. •Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization

  3. •Bilateral orchiectomy

  4. •History of pelvic radiation

  5. •Prior systemic (example [e.g.], chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer

  6. •History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)

  7. •Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer

  8. •Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer

  9. •Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study

  10. •Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization

  11. •Use of any investigational agent <=4 weeks prior to randomization

  12. •Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations

  13. •Major surgery <=4 weeks prior to randomization

  14. •Current or prior treatment with anti-epileptic medications for the treatment of seizures

  15. •Gastrointestinal conditions affecting absorption

  16. •Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations

  17. •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Vannes - Centre Hospitalier Bretagne Atlantique - - / Non 09/08/2019
Vannes - Centre D'Oncologie St Yves Dr E. Montpetit - MERLET A. - antoine.merlet@ch-bretagne-atlantique.fr NC / NC Non 14/02/2019
Plérin - CARIO - HPCA Dr Vie - Aude Vincent - a.vincent@bec22.fr / Non 18/06/2018
Brest - CHU de Brest - Site Morvan Dr J. P. Malhaire - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr

Toutes spécialités sauf hématologie pédiatrique

1 / Oui 24/06/2019
Afficher les détails
Acronyme : CABASTY
Spécialité : Oncogériatrie
Traitement : Métastatique
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Arm A
Cabazitaxel 25 mg/m² intravenously over 1 hour on Day 1of a 3-week cycle, plus prednisone (or prednisolone) 10 mg orally given daily for a maximum of 10 cycles (ie 30 weeks of treatment).

Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every cycle of cabazitaxel.

Experimental: Arm B
Cabazitaxel 16 mg/m2 on Day 1 and Day 15 of a 4-week cycle plus prednisone (or prednisolone) 10 mg per day up to 10 cycles (ie 40 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every cycle of cabazitaxel."

Informations

Oncogériatrie

Castration resistant métastatic cancer

Prostate

Phase: 3

Promoteur: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Autre(s) acronyme(s): NR
Contact promoteur: Réza ELAIDI, PhD
Elena BRAYCHENKO, MD

Mail promoteur: reza-thierry.elaidi-ext@aphp.fr
elena.braychenko-ext@aphp.fr
Tel promoteur: 00 33 (1)56 09 23 40 reza-thierry.elaidi-ext@aphp.fr
00 33 (1)56 09 34 34 elena.braychenko-ext@aphp.fr

Coordonnateur: Stephane OUDARD, MD Hôpital Européen Georges Pompidou, Oncology Department

-
Source: clinicaltrials.org 04/08/2017"

Cet essai dans d'autres annuaires :

Titre :

Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 70 Years) With mCRPC Previously Treated With a Docetaxel-containing Regimen

Critères d'inclusion :
  1. "Patient aged ≥ 70 years with mCRPC previously treated with docetaxel Sponsor Protocol: CABASTY Date 6thJune 2016 Version 4.0 - Confidential Page 6 of 58

  2. Medical or surgical castration with castrate level of testosterone (< 50 ng/dl)

  3. Progressive disease according to physician judgement

  4. Histologically proven prostate carcinoma

  5. Health status allowing use of chemotherapy: G8 > 14; or G8 score ≤ 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy

  6. ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)

  7. Adequate hematologic, liver and renal functions:

    Neutrophil count ≥1.5 109/L

    Haemoglobin ≥10 g/ dL

    Platelet count ≥100.109/L

    Total bilirubin ≤ 1 the upper limit of normal (ULN)

    Transaminases ≤ 1.5 ULN

    Serum creatinine ≤ 2.0 ULN

  8. Ongoing LHRH therapy at study entry

  9. Signed informed consent"

Critères de non-inclusion :
  1. "History of severe hypersensitivity reaction (≥grade 3) to docetaxel

  2. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs

  3. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)

  4. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)

  5. PS >2 not related to prostate cancer disease

  6. G8 ≤ 14 with geriatric assessment contra-indicating standard cabazitaxel regimen

  7. Concomitant vaccination with yellow fever vaccine

  8. Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons

  9. Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - Clinique Pasteur Lanroze Dr A. Hasbini - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com 6 / NC Oui 04/06/2019
Plérin - CARIO - HPCA Dr Dominique BESSON - Aude Vincent - a.vincent@bec22.fr / Oui 19/03/2018
Afficher les détails
Acronyme : CONCORDE III PRODIGE 26
Spécialité : Digestif
Traitement : Radio-chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: ARM A
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
Radiotherapy 40 Gy, in 20 fractions / 4 weeks: PTV (1cm in every direction)
Boost 10 Gy in 5 fr: PTV = +1cm.
Chemotherapy FOLFOX 4: 6 treatments in 3 courses concomitant to the radiotherapy (D1, D15, D29)
Interventions:
Radiation: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node
Radiation: Boost
Drug: chemotherapy: FOLFOX 4


Experimental: ARM B
Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
40 Gy in 20 fractions / 4 weeks, PTV (1cm in every direction)
Boost 26 Gy in 13 fr: PTV = +1cm.
Chemotherapy: FOLFOX 4: 6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43).
Interventions:
Radiation: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node
Radiation: Boost
Drug: chemotherapy: FOLFOX 4

Intervention :
Radiation: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node
40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)
Radiation: Boost
Boost 10 Gy in 5 fr, PTV = +1cm.
Radiation: Boost
Boost 26 Gy in 13 fr, PTV = +1cm.
Drug: chemotherapy: FOLFOX 4
6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43) arm B or 3 courses concomitant to radiotherapy (D1, D15, D29) arm A.

Informations

OESOPHAGE - Carcinomes épidermoides ou adénocarcinomes

locallement avancés ou non opérables

Phase: 3

Promoteur: UNICANCER
FFCD
Acronymes: CONCORDE III PRODIGE 26
Contact promoteur: Emilie REDERSTORFF, PHD
Mail promoteur: ERederstorff@cgfl.fr
Sandrine Tiago stiago@cgfl.fr
Tel promoteur: 3 80 73 75 00 ext 3461
3 45 34 80 51 ext +33
Coordonnateur: Gilles CREHANGE, MD

Mail coordonnateur: gcrehange@cgfl.fr
Tel Coordonnateur: 3 80 73 75 18 ext +33
-
Source: Clinicaltrials.org 26/10/17

Cet essai dans d'autres annuaires :

Titre :

Prodige 26 phase 2: Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

Critères d'inclusion :
  1. Age > or = 18 and < 75 ans

  2. WHO Status 0, 1 and 2

  3. Enteral or parenteral feeding (>or = 1500 KCal) planned before the start of treatment

  4. Histologically proven carcinoma of the oesophagus

  5. Histological Types: adenocarcinomas and epidermoid carcinomas

  6. T3, N0-N1-N2-N3, M0 (TNM version 7)

  7. T1-T2, N0-N1-N2-N3, M0 with a contra-indication for surgery (TNM version 7)

  8. Absence of trachea-oesophageal fistula

  9. Written informed consent

  10. Woman under appropriate contraception

  11. Patient able to understand and complete, with help if necessary, a quality of life questionnaire

Critères de non-inclusion :
  1. Evolutive heart failure or myocardial necrosis for less than 6 months

  2. Myocardial infarction of more than 6 months with ischemic sequelae on myocardial scintigraphy.

  3. Patient cannot absorb at least 1500kcal/j before and/or during treatment

  4. Left heart failure.

  5. Stage II to IV arteriopathy in the Leriche and Fontaine classification

  6. Creatinine > or = 1.25x N

  7. PNN < 1,5.109 /l2,0.109 /l ou 2000/mm3 (amendement n°42 )

  8. Platelets < 100. 109 /l

  9. Albumin < 30g/l

  10. TP < 60% without anticoagulant

  11. VEMS < 1l

  12. History of cancer (except baso-cellular cutaneous epithelioma or in situ epithelioma of the cervix) that has relapsed in the 5 years preceding recruitment for the trial

  13. Patient already enrolled in another therapeutic trial with an experimental molecule

  14. Women who are pregnant or likely to be so, or who are breastfeeding

  15. People who are in custody or under guardianship

  16. Impossibility to adhere to the medical follow up for the trial for geographical,social or psychiatric reasons.

  17. Presence of a history of radiotherapy to the chest or upper abdomen for another tumour

      18. Peripheral neuropathy > or = grade 1 (CTC v3.0)

Amendement n°42 :

19. potassium < LIN-3.0 mmol/L

20. Magnesium <  LIN - 1.2 mg/dL ou 12 mg.L ou LIN - 0.5 mmol/L

21. Calcium : calcium corrigé <  LIN - 8 mg/dL ; <  LIN - 2.0 mmol/L; calcium ionisé <  LIN-1.0 mmol/L

22. Clairance de la créatinine <  30 ml/mn

23. Un intervalle QT/QTc > 450 msec pour les hommes et > 470 pour les femmes

24. Patient avec un déficit complet connu en dihydropyrimidine déshydrogénase (DPD)

25. Vaccination avec le accin de la fièvre jaune

26. Contre indications à l'utilisation des produits utilisés dans cet essai (5-fluorouracile, oxaliplatine et acide folinique).

Les contres indications sont disponibles dans la verson actualisée des RCP des AMM des produits utilisés dans cet essai sur le site : http://base-donnees-publique.medicaments.gouv.fr  (ANNEXE 11)

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
ANGERS - Institut de Cancérologie de l'Ouest Dr RIO Emmanuel - - / Oui 11/05/2018
NANTES - Institut de Cancérologie de l' Ouest RIO Emmanuel - - / Oui 11/05/2018
Rennes - Centre Eugène Marquis - O. Zekri - o.zekri@rennes.unicancer.fr / Oui 29/01/2018
Plérin - CARIO - HPCA Dr Pierre-Luc ETIENNE - Aude Vincent - a.vincent@bec22.fr / Oui 19/03/2018
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