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348 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : Intellance1 M13-813 2015-001166-26
Spécialité : Neurologie
Traitement : Radio-chimiothérapie adjuvante
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: ABT-414, radiation and TMZ
ABT-414 is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. ABT-414 is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Interventions:
Drug: ABT-414
Radiation: Radiation
Drug: Temozolomide

Placebo Comparator: Placebo, radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Interventions:
Radiation: Radiation
Drug: Temozolomide
Drug: Placebo for ABT-414

Informations

Glioblastoma
Gliosarcoma

Amplification EGFR

Phase 2

Promoteur: ABBVIE / Radiation Therapy Oncology Group
Contact promoteur: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

Coordonnateur: Earle Bain, MD AbbVie

Source: clinicaltrials.org 20/10/2017

Cet essai dans d'autres annuaires :

Titre :

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

Critères d'inclusion :
  1. Must have a clinical diagnosis of Glioblastoma (GBM)

  2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue

  3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100 (N/A to the sub-study)

  4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery

  5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)

Critères de non-inclusion :
  1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM)

  2. Prior chemo therapy or radiosensitizer for head and neck cancer

  3. Prior radiotherapy to the head or neck in overlap of radiation fields

  4. Prior therapy for glioblastoma or other invasive malignancy

  5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy

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 FRENEL Jean Sebastien - SEMELIN Sophie - / Oui 11/05/2018
NANTES - Institut de Cancérologie de l' Ouest FRENEL Jean Sébastien - BELCHEVA Sabina - / Oui 28/01/2019
Afficher les détails
Acronyme : INNEOV GINECO-OV127b INNEOV-Ovaire INeOV
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée néoadjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

Drug: ARM A Durvalumab/chemotherapy association

NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)

ADJUVANT :

  • If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.

  • If residual tumor at interval debulking surgery : the tremelimumab 75 mg IV will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab 1125 mg IV (with one cycle of tremelimumab 75 mg IV post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.

Drug: ARM B Durvalumab/Tremelimumab/chemotherapy association

NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)

ADJUVANT :

  • If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.

  • If residual tumor at interval debulking surgery : patients will be treated according to investigator choice.

Informations

Cancer de l'ovaire, des trompes de fallopes et péritoine

1ière ligne avancée métastatique néoadjuvant

1ière ligne avancée métastatique adjuvant

Ouverture de la phase d'expansion février 2019

Phase: 1, 2

Promoteur: ARCAGY/ GINECO GROUP

Acronymes: INNEOV GINECO-OV127b INNEOV-Ovaire INeOV
Contact promoteur:
Contact: Magali CESANA

Mail promoteur: mcesana@arcagy.org
Tel promoteur: 01 42 34 83 23
Coordonnateur: Alexandra LEARY, MD, PhD

-
Source: Clinicaltrials.gov du 21/06/2018"

Cet essai dans d'autres annuaires :

Titre :

A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy

Critères d'inclusion :
  • I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with newly histologically confirmed epithelial ovarian cancer (or fallopian tube or primary peritoneal adenocarcinoma).

  • I-4 Advanced FIGO stage IIIC to IV.

  • I-5 Patients for whom primary debulking surgery has been denied after an evaluation through laparoscopy or laparotomy.

  • I-6 Patient for whom a neo-adjuvant strategy has been planned.

  • I-7 Interval between diagnosis and enrolment (informed consent signed) ≤ 8 weeks.

  • I-8 Eastern Cooperative Oncology Group (ECOG) performance status 0.

  • I-9 Geriatric vulnerability score (GVS) < 3 for patients ≥ 70 years.

  • I-10 Adequate organ and bone marrow function.

  • I-11 Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.

  • I-12 As this study will include patients in France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social category.

Critères de non-inclusion :
  1. E-1 Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).

  2. E-2 Major surgical procedure (defined by the resection of at least one organ including ovary) within 28 days prior to the first dose.

  3. E-3 Any concurrent chemotherapy, investigational product, biological, or hormonal therapy for cancer treatment.

  4. E-4 Previous treatment with immunotherapy, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, or therapeutic anticancer vaccine.

  5. E-5 Active or prior documented autoimmune or inflammatory disorders The following are exceptions to this criterion:

    Patients with vitiligo or alopecia,

    Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.

  6. E-6 Current/prior immunosuppressive medication ≤ 14 days before first durvalumab and tremelimumab dose (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.

  7. E-7 Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.

  8. E-8 Uncontrolled diabetes mellitus, uncontrolled hypothyroidism. E-9 Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half- lives of the drug (whichever is shorter) prior to Cycle 1, Day 1.

  9. E-10 History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted.

  10. E-11 Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1. E-12 Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza.

  11. E-13 Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.

  12. E-14 Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.

  13. E-15 Inadequately controlled HTN (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).

  14. E-16 Clinically significant (e.g. active) cardiovascular disease, including:

    Myocardial infarction or unstable angina within ≤ 6 months of randomization,

    New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),

    Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),

    Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision).

  15. E-17 Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.

  16. E-18 History or evidence of hemorrhagic disorders within 6 months prior to randomization.

  17. E-19 Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).

  18. E-20 History or clinical suspicion of brain metastases or spinal cord compression unless asymptomatic, treated, and stable off steroids and anti-convulsants for at least 1 month prior to entry.

  19. E-21 History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).

  20. E-22 Pre-existing motor or sensory neurotoxicity (grade > 1). E-23 Significant traumatic injury within 4 weeks prior to randomization. E-24 Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations.

  21. E-25 Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.

  22. E-26 Previous allogeneic bone marrow transplant or previous solid organ transplantation.

  23. E-27 Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.

  24. E-28 Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.

  25. E-29 Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential (< 2 years after last menstruation and not surgically sterile) who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.

  26. E-30 History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

  27. E-31 Known hypersensitivity or allergy to biopharmaceuticals or to any component of the durvalumab or tremelimumab formulations.

  28. E-32 Known hypersensitivity reaction or allergy to drugs chemically related to carboplatin, paclitaxel, or their excipients that contraindicates the subject's participation.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CLIP² Dr T. DE LA MOTTE ROUGE - - / Oui 13/01/2020
Rennes - Centre Eugène Marquis Dr Thibault de la MOTTE-ROUGE - O. Zekri - o.zekri@rennes.unicancer.fr / Oui 28/02/2019
Afficher les détails
Acronyme : INIM ICT-10
Spécialité : Hématologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

To assess the efficacy of inecalcitol in combination with imatinib in chronic myeloid leukaemia patients with molecular residual disease on imatinib monotherapy.
(inecalcitol oral)

Informations

Residual disease in Chronic Myeloid Leukaemia

Thérapie ciblée

Phase: 2

Promoteur: HYBRYGENICS SA
Autre(s) acronyme(s): ICT-10
Contact promoteur: Jean-François Dufour-Lamartinie
Mail promoteur: jfdufour@hybrigenics.com
Tel promoteur: Tel: 33158103805/08
Fax: 33158103840

-
Source: EU Clinical Trials Register 10/10/2016

Cet essai dans d'autres annuaires :

Titre :

Etude de Phase 2 Visant à Evaluer l’Efficacité et la Tolérance de l'Inécalcitol dans la Maladie Résiduelle de la Leucémie Myéloïde Chronique Traitée par Imatinib : Etude INIM

Critères d'inclusion :
  1. • Men or women aged of at least 18 years at the time of informed consent signature;

  2. • Patients have signed written informed consent;

  3. • ECOG performance status < 2;

  4. • Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity (e13a2 ou e14a2);

  5. • Treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated);

  6. • Patient in complete cytogenetic response with BCR-ABL/ABL status between 0.1% International Scale (IS) and 0.01% IS and no BCR-ABL checkpoint in the last six months better than Molecular Response MR4 (i.e. BCR-ABL ratio < 0.01% IS); 

  7. • Women of child bearing potential have a negative pregnancy test prior to first dose and agree to practice effective contraception during the study;

  8. • Fertile men agree to practice effective contraception during the study;

  9. • Patients agree to comply with the study requirements and agree to come to the clinic for required study visits;

  10. • Patients agree to follow medication restrictions during the study;

Critères de non-inclusion :
  1. • Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2)

  2. Pregnant or lactating women;

  3. • Participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except from OPTIM imatinib);

  4. • Treatment with interferon within the last 24 months;

  5. • Imatinib dose modification within the last 3 months;

  6. • Prior history of haematopoietic stem cell transplantation;

  7. • Impaired renal function with creatinine clearance < 30 ml/min/1.73m² according to the MDRD formula;

  8. • Hypercalcemia (corrected with albuminemia);

  9. • History of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis….;

  10. • Presence or history of symptomatic kidney stones in the last 5 years;

  11. • Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, bisphosphonates, and calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium);

  12. • Current use of digitalis;

  13. • Current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders);

  14. • Patients with a chronic condition which is not well controlled that, according to the investigator, would interfere with the completion of the study;

  15. • Use of any other experimental drug, therapy or vitamin D supplementation within 30 days of first inecalcitol administration;

  16. • Patients with a mental deficiency preventing proper understanding of trial protocol requirements;

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. A. Tempescul - NICOLAS Isabelle - 2 / 4 Non 18/06/2018
St Brieuc - Centre Hospitalier Yves Le Foll Dr O. ALLANGBA/Dr V. LAUNAY/... - Catherine BELLOT - catherine.bellot@ch-stbrieuc.fr / Non 14/06/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Martine Escoffre-Barbe - Hayat Djelti - hayat.djelti@chu-rennes.fr 2 / 3 Non 14/06/2018
Afficher les détails
Acronyme : INCB054828 INCB 54828-201
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: Cohort A INCB054828
INCB054828 in subjects with FGFR3 mutations or fusions
Drug: INCB054828
INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off therapy


Experimental: Cohort B INCB054828
INCB054828 in subjects with other FGF/FGFR alterations
Drug: INCB054828
INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off therapy

Informations

Carcinome urothélial avec altération FGF/FGFR

may include primary site from ureters, upper tract, renal pelvis, and bladder.

métastatique ou inopérable

"1iere ligne pour ECOG faible ou insuffisance rénale ou

2ème ligne ou plus métastatique
non prétraité par un inhibiteur FGFR "

Phase: 2

Promoteur: INCYTE Corporation
Acronymes: INCB054828  INCB 54828-201
Contact promoteur: Ekaterine Asatiani, MD - Call Center1.855.463.3463
Source: clinicaltrials.gov  19/01/2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Critères d'inclusion :
  1. Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

  3. Life expectancy ≥ 12 weeks.

  4. Radiographically measurable per RECIST v1.1.

  5. Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.

Critères de non-inclusion :
  1. Prior receipt of a selective FGFR inhibitor.

  2. Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.

  3. Inability or unwillingness to swallow INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828.

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 DELVA Remy - - / Oui 11/05/2018
NANTES - Institut de Cancérologie de l' Ouest ROLLAND Frederic - - / Oui 11/05/2018
Afficher les détails
Acronyme : IntReALL HR 2010
Spécialité : Hématologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

The IntReALL HR 2010 trial is an inter-group, international multi-centre, treatment optimization
trial. It contains the following treatment arms:
- induction: prospective, randomized, adaptive, open label phase II trial comparing arm A
(modified ALL R3) versus arm B (modified ALL R3 + bortezomib).
- post-induction single arm observational trial with intensive multidrug chemotherapy courses
HC1 (modified AIEOP-BFM ALL 2009 HR1), HC2 (modified HR3)
- a third post-induction chemotherapy block HC3 (modified AIEOP-BFM ALL HR2) may
optionally be given within the IntReALL HR 2010 trial or used as standard comparator for an
investigational window trial
- all patients in morphological CR2 will be subjected to allogeneic HSCT
- termination of the trial after completion of the 2nd or 3rd consolidation block before
investigational window trial and/or allogeneic HSCT. Follow-up will be done until reaching
secondary EFS / OS endpoints.
- patients with insufficient treatment response (MRD ≥ 10-3 after induction) may be allocated to
individualized consolidation therapy based on individual biologic features of the leukemia, if
such approaches are available

Informations

LLA à haut risque de rechute chez l'enfant

Phase: 2
Promoteur: Charité - Universitätsmedizin Berlin
Acronymes: IntReALL HR 2010 2012-000810-12
Contact promoteur: Co-Sponsor: CHU of Nice
• National Coordinator: Pr Pierre Rohrlich , rohrlich.ps@chu-nice.fr
• Clinical project manager – DRCI: Valérie Foussat, foussat.v@chu-nice.fr
04 92 03 63 77
• Study monitor: Jérémy Tobia, tobia.j@chu-nice.fr
04 92 03 66 64

Source: Protocol Version 2.2, Date 21. July 2017
Eudra-CT Number: 2012-000810-12

Titre :

International Study for Treatment of High Risk Childhood Relapsed. Improvement of CR2 rates after induction with ALL R3 with bortezomib versus without bortezomid in HR relapsed ALL patients

Critères d'inclusion :

Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
Children less than 18 years of age at date of inclusion into the study
Meeting HR criteria (any T BM relapse, early/very early isolated BM relapse, very
early isolated/combined extramedullary relapse)
Patient enrolled in a participating centre
Written informed consent
Start of treatment falling into the study period
No participation in other clinical trials 30 days prior to study enrolment except trials for
primary ALL

Critères de non-inclusion :

BCR-ABL / t(9;22) positive ALL
Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
Sexually active adolescents not willing to use highly effective contraceptive method
(pearl index <1) until 12 months after end of antileukemic therapy
Breast feeding
Relapse post allogeneic stem-cell transplantation
Neuropathy > II°
The whole protocol or essential parts are declined either by the patient himself/herselfor the respective legal guardian
Lodge an objection to the study participation by a minor patient, able to object
Any patient being dependent on the investigator
No consent is given for saving and propagation of pseudonymized medical data for
trial reasons
Severe concomitant disease that does not allow treatment according to the protocol
at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations,
metabolic disorders)
Subjects unwilling or unable to comply with the study procedures
Subjects who are legally detained in an official institute

Allowed systemic diseases and concomitant medication
Patients with systemic diseases, who presumably will tolerate the protocol treatment without
primary treatment reductions (f.e. cystic fibrosis or diabetes mellitus may be eligible for
enrolment in this trial) can be included. Patients with Down syndrome usually require primary
treatment reductions and would not be eligible for additional treatment intensification with the
bortezomib randomization.
Any kind of concomitant medication given due to medical reasons is allowed except antileukemic
therapy and investigational drugs other than scheduled in the protocol.

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. L. Carausu - BIHANNIC Nathalie - NC / NC Oui 18/06/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou - - / Oui 15/03/2018
Afficher les détails
Acronyme : IntReALL SR 2010
Spécialité : Hématologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

No Intervention: SR-A
Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.

Active Comparator: SR-A + Epratuzumab
Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab.

No Intervention: SR-B
Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized not to receive epratuzumab.

Active Comparator: SR-B + Epratuzumab
Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized to receive epratuzumab.

Informations

Rechute de haut risque de LLA

Phase: 3
Promoteur: Charité Universitatmedizin Berlin
Autre(s) acronyme(s): NR
Contact promoteur: NR
Coordonnateur: NR
-
Source: clinicaltrials.gov du 16/09/2015

Cet essai dans d'autres annuaires :

Titre :

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Critères d'inclusion :
  • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL

  • Children less than 18 years of age at inclusion

  • Meeting SR criteria: late isolated or late/early combined BCP BM relapse, any late/early isolated extramedullary relapse

  • Patient enrolled in a participating centre

  • Written informed consent

  • Start of treatment falling into the study period

  • No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization

  • Precursor B-cell immunophenotype. A specific CD22 expression level is not required

  • M1 or M2 status of the bone marrow after induction

Critères de non-inclusion :
  • BCR-ABL / t(9;22) positive ALL

  • Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)

  • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 2 years after end of antileukemic therapy

  • Breast feeding

  • Relapse post allogeneic stem-cell transplantation

  • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian

  • No consent is given for saving and propagation of pseudonymized medical data for study reasons

  • Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)

  • Karnovsky / Lansky score < 50%

  • Subjects unwilling or unable to comply with the study procedures

  • Subjects who are legally detained in an official institute

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. L. Carausu - BIHANNIC Nathalie - 0 / nc Oui 18/06/2018
Rennes - CHU Rennes - Site Hôpital Sud Pr Virginie Gandemer - Isabelle Debroise - Isabelle.DEBROISE@chu-rennes.fr NC / NC Oui 12/06/2018
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Acronyme : IROCAS UC-0110/1609_PRODIGE52 / UCGI29 prodige 52
Spécialité : Digestif
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

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Phase(s) : Phase III
Descriptif

Experimental: Arm A
mFOLFIRINOX Folfox Protocol + Irinotecan

Active Comparator: Arm B
mFOLFOX 6 Folfox Protocol
Intervention: Drug: Folfox Protocol

"Drug: Irinotecan
every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started
Other Name: Campto

Drug: Folfox Protocol
every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion
Other Name: acid folinic + oxaliplatine + 5FU"

Informations

Cancer du colon à haut risque

High-risk Stage III; pT4N1 or pT1 to 4 N2

Chimiothérapie adjuvante

Phase: 3

Promoteur: UNICANCER
Autre(s) acronyme(s): UC-0110/1609_PRODIGE52/UCGI29 prodige 52
Contact promoteur: Contact: Beata JUZYNA
Contact: Claire JOUFFROY

Mail promoteur: b-juzyna@unicancer.fr
c-jouffroy@unicancer.fr

Coordonnateur:
Study Chair: Jaafar BENNOUNA, Professor ICO René Gauducheau, Nantes - Angers
Study Chair: Julien TAIEB, Professor Hôpital Européen Georges-Pompidou, PARIS
Study Chair: Thierry ANDRE, Professor AP-HP Hôpital Saint-Antoine, PARIS

-
Source: clinical trials org 07/03/2017"

Cet essai dans d'autres annuaires :

Titre :

"A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting "

Critères d'inclusion :
  1. "Patient ≥18 years and < 71years

  2. Patient with ECOG ≤1

  3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.

  4. Curative R0 surgical resection within 42 days before randomization.

  5. Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent

  6. Start of study drug treatment has to be performed less than 56 days after surgery.

  7. No prior chemotherapy.

  8. No prior abdominal or pelvic irradiation.

  9. Patient with adequate organ function: Absolute neutrophil count (ANC) ≥ 2 x 109/L Haemoglobin ≥9 g/dL Platelets (PTL) ≥100 x 109/L AST/ALT ≤2.5 x ULN Alkaline phosphatase ≤2.5 x ULN Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal) Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula) Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal) Carcinoembryogenic antigen (CEA) ≤10ng/mL after surgery (during screening period)

  10. Adequate contraception if applicable.

  11. Patient able and willing to comply with study procedures as per protocol

  12. Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures

  13. Public or private health insurance coverage

  14. Life expectancy of > or = at 5 years"

Critères de non-inclusion :
  1. "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study

  2. Metastatic disease

  3. Presence of inflammatory bowel disease and/or ileus

  4. Known hypersensitivity reaction to any of the components of study treatments.

  5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period

  6. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QT/QTc ≥450 msec, for women: QT/QTc ≥470 msec)

  7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix

  8. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent

  9. History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.

  10. Any significant disease which, in the investigator's opinion, would exclude the patient from the study.

  11. Known DPD deficiency or UGT1A1 homozygous 7/7

  12. Patients already included in another therapeutic trial involving an experimental drug"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Pierre-Luc ETIENNE - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 24/09/2019
Saint Malo - Clinique de la Côte d'Émeraude - - / Oui 03/06/2019
Lorient - Centre Hospitalier Bretagne Sud Dr Isabelle Cumin - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 12/02/2019
Saint Malo - Centre Hospitalier de Saint Malo Dr Desgrippes - Stéphane Natur - Stephane.natur@ch-stmalo.fr 1 / 5 Oui 12/09/2019
St Brieuc - Centre Hospitalier Yves Le Foll Dr JB DELOBEL - Catherine BELLOT - catherine.bellot@ch-stbrieuc.fr NC / NC Oui 06/11/2018
Saint Malo - Clinique de la Côte d'Émeraude Dr Raoul - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Oui 07/03/2017
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Miglianico - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Oui 07/03/2017
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Acronyme : IPH2102-201
Spécialité : Hématologie
Traitement : Entretien
Ouvert aux inclusions : Oui

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Phase(s) : Phase III
Descriptif

 Chaque cycle de traitement sera administré tous les 28±7 jours avec un maximum de 24
cycles.
 Les traitements des 3 bras sont les suivants :
o IPH2102 : 0.1 mg/kg toutes les 12 semaines par voie intraveineuse d’une durée d’1 heure. Les patients recevront IPH2102 aux cycles 1, 4, 7, 10, 13, 16, 19 et 22 et ils recevront le Placebo (solution saline normale) aux cycles 2, 3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 18, 20, 21, 23 et 24 par voie intraveineuse d’une durée d’1 heure. Cette dose provoque une occupation intermittente des récepteurs KIR.
o IPH2102 : 1 mg/kg toutes les 4 semaines par voie intraveineuse d’une durée d’1 heure. Cette dose provoque une occupation permanente des récepteurs KIR.
o Placebo (solution saline normale) : toutes les 4 semaines par voie intraveineuse d’une durée d’1 heure.
Aucune prémédication n’est requise. Cependant, à partir du cycle 2 une prémédication avec paracétamol et d’anti-histaminique peut être prescrite selon la décision de l’investigateur si le patient a reporté des évènements indésirables de grade 1 à 3 lié à la perfusion au cycle précédent.
IPH2102 peut être administré en Hôpital de Jour.

Informations

Nom du promoteur: INNATE PHARMA
Autres acronymes de l'étude: non renseigné
Contact promoteur: non renseigné
Mail contact promoteur: non renseigné
Téléphone contact promoteur:
Coordonnateur: Pr. Norbert Vey (Institut Paoli Calmettes, Marseille)
-
Source des informations sur le protocole :non renseigné

Titre :

Etude de phase 2 randomisée, menée en double-aveugle, contre placebo évaluant IPH2102 comme traitement d'entretien de la Leucémie Aiguë Myéloïde chez des patients âgés en première réponse complète.

Critères d'inclusion :

1) Leucémie Aiguë Myéloïde (LAM) primaire ou secondaire en première réponse complète

(RC/RCi) après avoir reçu une chimiothérapie d’induction et 1 ou 2 cycles de consolidation. La chimiothérapie d’induction devra être effectuée dans les 6 mois qui précèdent la randomisation. Un cycle de consolidation est défini par une chimiothérapie administrée dans les 3 mois qui suivent l’obtention de la réponse complète et qui contient de l’aracytine quelle que soit la dose. Au moins 1 et au maximum 2 cycles de consolidation doivent avoir été administrés avant l’inclusion dans l’étude.

2) Patient non éligible à une greffe allogénique de cellules hématopoïétiques

3) Agés de 60 à 80 ans

4) Evaluation de performance ECOG de 0 ou 1

5) Valeur clinique de laboratoire au screening :

- Clairance de la créatinine calculée (selon MDRD) > 60 ml/min/1,73 m2

- Plaquettes > 75 x 109 /l

- Hémoglobine ≥ 10 g/dl avec ou sans transfusion

- Neutrophiles > 1 x 109 /l

- Bilirubine totale ≤ 1.5 ULN

- ALT et AST ≤ 3 ULN

6) Résolution de toxicité aigüe des traitements anti-tumoraux antérieurs

7) Les patients de sexe masculin doivent accepter d’utiliser une méthode de contraception efficace reconnue durant toute la durée de l’essai.

8) Consentement signé et obtenu avant toute procédure relative à l’étude.

Critères de non-inclusion :

1) Leucémie Aigue Promyélocytaire avec translocation (15 ;17) ou ses équivalents moléculaires (PML-RARA)

2) LAM de « risque favorable » avec t(8/21) ou inv(16 ; 16) et t(16;16) et leurs équivalents moléculaires (AML-ETO et CBFB-MYH11).

3) Dernier cycle de consolidation reçu plus de 3 mois avant la première administration.

4) Traitement concomitant par chimiothérapie / immunothérapie ou par corticostéroïdes administrés par voie systémique

5) Dernière administration de chimiothérapie à dose standard ou de traitement corticostéroïde systémique dans les 28 jours précédant la première administration

6) Antécédent de greffe allogénique de cellules hématopoïétiques ou de transplantation d’organe solide

7) Antécédent de chimiothérapie à haute dose et greffe autologue de cellules hématopoïétiques comme traitement de LAM

8) Utilisation de tout produit expérimental dans les 2 mois précédant la première administration d’IPH2102

9) Utilisation de facteurs de croissance (G- or GM-CSF or EPO) dans les 28 jours précédant la première administration d’IPH2102

10) Toute irradiation durant les 3 derniers mois précédant la première administration du produit à ’étude sauf à visée analgésique

11) Dialyse intermittente ou continue

12) Etat cardiaque anormal avec un des points suivants :

- Fraction d’éjection (mesurée par échocardiographie ou scintigraphie cardiaque) en dessous de 50%

- Infarctus du Myocarde durant les 6 derniers mois

- QTc ≥ 480 ms

13) Infection active en cours ou sérologie positive au VIH, et/ou VHC avec virémie détectable et/ou VHB avec Antigènes Hbs positifs et/ou Anticorps antiHbs négatifs

14) Maladie auto-immune :

 Qui nécessite ou a nécessité un traitement systémique par immunosuppresseur ou immuno-modulateur (incluant les corticoïdes par voie systémique).

 Et qui a une probabilité substantielle de causer des dommages tissulaires irréversibles.

 Et/ou qui est récente ou instable et a un risque substantiel de progresser et de causer des complications sévères.

15) Pathologie associée grave et non contrôlée

16) Antécédents d’autre(s) cancer(s) dans les 3 années précédentes (sauf syndrome myélodysplasique, carcinome baso-cellulaire de la peau et carcinome cervical in situ)

17)Tout état psychologique, familial, sociologique ou situation géographique qui pourrait gêner l’observance de l’étude et son suivi.

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 - Guillaume Drugmanne - guillaume.drugmanne@chu-brest.fr NC / NC Oui 21/01/2015
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Acronyme : IONESCO IFCT-1601
Spécialité : Pneumologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

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Phase(s) : Phase II
Descriptif

Experimental: Durvalumab
durvalumab 750 mg IV J1, J15, J29
Drug: Durvalumab


durvalumab 750 mg IV Day1, 15, 29
Other Name: MEDI4736

Informations

Cancer bronchique non à petites cellules

Stade Ib, II

Néoadjuvant

Phase 2:

Promoteur: IFCT
Autre(s) acronyme(s):IONESCO IFCT-1601
Contact promoteur: Elodie AMOUR
Mail promoteur:contact@ifct.fr 

Source:clinicaltrials.gov 17/01/2018

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer

Critères d'inclusion :
  1. Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.

  2. Tissue block of diagnosis must be available for submission after inclusion (one HES slide and one paraffin embedded block).

  3. Patients must be classified clinically as Stage IB (> 4cm in the longest diameter), II on the basis of clinical evaluation of 2009 TNM criteria. A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain as well as thorax abdomen pelvis CT scan must be done prior to surgery and before inclusion. If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, invasive mediastinal staging with mediastinoscopy or EBUS-TBNA must be performed. Station 5 or 6 lymph nodes may be accessed by anterior mediastinotomy or VATS.

  4. Pre-operative (neo-adjuvant) platinum based or other chemotherapy except the treatment of the protocol is not permissible. Pre-operative radiation therapy is not permissible

  5. The patient must have an ECOG performance status of 0, 1.

  6. Hematology (done within 14 days prior to inclusion and with values within the ranges specified below): If anemic, patients should be asymptomatic and should not be decompensated. Transfusions are permissible. Haemoglobin ≥ 9,0 g/dL Absolute neutrophil count > 1.5 x 109/L or > 1,500/µl Platelets > 100 x 109/L or > 100,000/µl

    - Biochemistry (done within 14 days prior to inclusion and with values within the ranges specified below): Total bilirubin* (* excluding Gilbert's syndrome) within normal institutional limits Alkaline phosphatase < 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal
     
    - Creatinine Clearance > 40 ml/min TSH within normal institutional limits
      Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:
      Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x  weight in kg serum creatinine in μmol/L
  7. Other investigations detailed in Section 6 must have been performed within the timelines indicated.

  8. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to inclusion in the trial to document their willingness to participate.

  9. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients included on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

  10. Protocol treatment is to begin within 7 days of patient inclusion

  11. Age of at least 18 years.

  12. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.

  13. Females of childbearing potential who are sexually active with a nonsterilized male partner or men who are sexually active with women of childbearing potential must use a highly effective method of contraception prior the first dose of investigational product, and must agree to continue using such precautions for 4 months after the final dose of investigational product. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Critères de non-inclusion :
  1. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.

  2. A combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour.

  3. History of autoimmune disease, 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. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from inclusion are not excluded.

  4. History of primary immunodeficiency, history of allogenic organ transplant, use of immunosuppressive agents within 28 days of inclusion* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.

    * NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.

  5. Live attenuated vaccination administered within 30 days prior to inclusion.

  6. History of hypersensitivity to durvalumab or any excipient.

  7. Mean QTc correction > 470msec using standard institutional method in screening ECG measured using standard institutional method or history of familial long QT syndrome.

  8. Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF > 50% within 12 weeks prior to inclusion.

  9. Concurrent treatment with other investigational drugs or anti-cancer therapy.

  10. Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:

    Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

    1. known prior history of tuberculosis;
    2. known acute hepatitis B or C by serological evaluation;
    3. known Human immunodeficiency virus infection.
  11. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab

  12. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)

  13. Known history of previous clinical diagnosis of tuberculosis

  14. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control

  15. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

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 22/05/2019
NANTES - Institut de Cancérologie de l' Ouest RAIMBOURG Judith - - / Oui 22/05/2019
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Acronyme : IMIREDUC
Spécialité : Dermatologie
Traitement : Autres traitements néoadjuvants
Ouvert aux inclusions : Oui

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Phase(s) : Phase III
Descriptif

•Experimental: Imiquimod
Intervention: Drug: Imiquimod cream + surgery
•Placebo Comparator: Placebo
Intervention: Drug: vehicle + surgery

Informations

Phase: 3
Promoteur: CHU DE NANTES
Autre(s) acronyme(s): BRD11/06-S
NCT01720407
Contact promoteur: Amir Khammari
Mail promoteur: amir.khammari@chu-nantes.fr
Tel promoteur: 02 53 48 32 80
Coordonnateur: Brigitte Dréno, MD, PhD
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: ClinicalTrials.gov du 04/07/2013

Titre :

Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

Critères d'inclusion :
  1. Patients from both sexes aged over 18 years and operable

  2. Presenting with LM of the face or the neck, histologically confirmed by biopsy

  3. Patients presenting with a primitive lesion, of a surface ≥ to 1.5cm² and ≤ to 20cm², with the possibility of graft or flap reconstruction

  4. LM previously untreated by surgery

  5. LM without prior treatment with liquid nitrogen or any other local treatment within 3 months

  6. ECOG ≤ 2

  7. leucocytes ≥ 3,000/mm³

  8. Neutrophil count ≥ 1,500/mm³

  9. Platelet count ≥ 100,000/mm³

  10. Haemoglobin ≥ 9.0g/dL

  11. Absence of severe evolutive infection

  12. Absence of known HIV infection

  13. Absence of corticotherapy and treatment by immunosuppressive agents

  14. Membership to a social security insurance scheme.

  15. Negative pregnancy test conducted during the inclusion consultation for non-menopausal women.

  16. Signed informed consent

Critères de non-inclusion :
  1. LM located on the eyelids are excluded, together with LM in anatomic sites other than the face or the neck

  2. Melanomas other than LM

  3. LM with a surface area < to 1,5cm² or > to 20cm²

  4. LM of which the macroscopic contours cannot be defined

  5. Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or corticosteroids (local and systemic) during the 4-week period prior to the selection visit

  6. Cutaneous reconstruction not possible

  7. Presence of associated evolutive neoplasia since less than 5 years (with the exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the cervix)

  8. Patient refusing surgery under local or general anaesthesia

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Dupuy - Alain.DUPUY@chu-rennes.fr UIC - 61 / 11 Oui 25/02/2019
Brest - CHU de Brest - Site Morvan Pr. L. Misery - laurent.misery@chu-brest.fr Clémence kergoulay - clémence.kergoulay@chu-brest.fr 13 / nc Oui 18/06/2018
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