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78 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : "ASCENT ASCENT-Sein IMMU-132-05"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: IMMU-132
Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)
Intervention: Drug: Sacituzumab govitecan

Active Comparator: Control Arm
Treatment of Physician's Choice determined before randomization from only one of the following treatments (see Appendix 2 for more details on administration and dosing management):
Eribulin (1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle). See section 6.5.1 Capecitabine (1000-1250 mg/m2 orally twice daily on Days1-14 of a 21-day cycle). See section 6.5.2 Gemcitabine (800-1200 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle). See section 6.5.3 Vinorelbine (25 mg/m2 weekly IV on Day 1 weekly) See section 6.5.4 (Note: eligible patients with Grade 2 neuropathy should not be prescribed vinorelbine as TPC)"

Informations

Cancer du sein triple négatif

Refractaire/récidive

3eme ligne et + (Doit avoir recu du taxane)

Phase: 3

Promoteur: IMMUNOMEDICS, Inc.
Acronymes: ASCENT NCT02574455
Contact promoteur: Heather Horne
Mail promoteur: hhorne@immunomedics.com
Tel promoteur: 973-605-8200
Coordonnateur: William Wegener, MD,PhD

-
Source: clinicaltrials.org
30/08/2019"

Cet essai dans d'autres annuaires :

Titre :

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

Critères d'inclusion :
  1. "Female or male patients, >18 years of age, able to understand and give written informed consent.

  2. Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.

  3. Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.

  4. Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.

  5. Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.

  6. ECOG performance score of 0 or 1 .

  7. Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.

  8. At least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery, and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).

  9. At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).

  10. Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).

  11. Adequate renal and hepatic function (creatinine ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).

  12. Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ≤ Grade 2 neuropathy are eligible).

  13. Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial."

Critères de non-inclusion :
  1. "Women who are pregnant or lactating.

  2. Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.

  3. Patients with Gilbert's disease.

  4. Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.

  5. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.

  6. Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.

  7. Infection requiring intravenous antibiotic use within one week of enrollment.

  8. Patients with a history of an anaphylactic reaction to irinotecan.

  9. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Véronique DIERAS - v.dieras@rennes.unicancer.fr - / Oui 07/11/2018
Afficher les détails
Acronyme : "BGB-290-303 2017-003493-13"
Spécialité : Digestif
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

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

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

Informations

Cancer de l'estomac locallement avancé inopérable ou métastatique

Ayant répondu à une première ligne de platine

maintenance

Phase: 3

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

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

Cet essai dans d'autres annuaires :

Titre :

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

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

  2. Signed informed consent.

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

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

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

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

  7. ECOG performance status ≤ 1.

  8. Adequate hematologic, renal and hepatic function.

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

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

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

  2. Prior treatment with PARP inhibitor.

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

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

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

  6. Other diagnoses of significant malignancy

  7. Leptomeningeal disease or brain metastasis

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

  9. Active infections requiring systemic treatment.

  10. Clinically significant cardiovascular disease

  11. Pregnant or nursing females."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 02/05/2018
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails
Acronyme : "CONTESSA ODO-TE-B301 CONTESSA-SEIN"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

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


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

Informations

Cancer du SEIN

Métastasique - Avancé

3ieme ligne et plus

Doit avoir recu

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

Ne doit pas avoir recu

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

Phase 3

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

Cet essai dans d'autres annuaires :

Titre :

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

Critères d'inclusion :

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

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

 

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

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

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

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

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

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

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

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

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

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

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

    Platelet count ≥ 100,000/μL

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

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

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

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

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

    Calculated creatinine clearance ≥ 50 mL/min

    Serum albumin ≥ 3.0 g/dL

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

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

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

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

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

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

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

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

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

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

Critères de non-inclusion :

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

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

  3. Prior treatment with capecitabine

  4. Known metastases to the central nervous system

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

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

  7. Active hepatitis B or active hepatitis C infection

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

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

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

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

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

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

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

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

  16. Pregnant or breastfeeding

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

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

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Véronique DIERAS - v.dieras@rennes.unicancer.fr Perrette Quéric - p.queric@rennes.unicancer.fr / Oui 24/08/2018
Afficher les détails
Acronyme : "IMpassion132 MO39193 2016-005119-42"
Spécialité : Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

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

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

Informations

Cancer du sein triple négatif

Locallement avancé, métastatique ou récidive

ayant recu anthracyclines et taxanes

Phase: 3

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

Cet essai dans d'autres annuaires :

Titre :

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

Critères d'inclusion :
  1. "Inclusion Criteria:

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

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

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

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

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

  7. Eastern Cooperative Oncology Group performance status 0-1

  8. Life expectancy ≥ 12 weeks

  9. Adequate haematologic and end-organ function

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

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

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

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

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

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

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

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

  3. Symptomatic or rapid visceral progression

  4. No prior treatment with an anthracycline and taxane

  5. History of leptomeningeal disease

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

  7. Uncontrolled tumour-related pain

  8. Uncontrolled or symptomatic hypercalcemia

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

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

  11. Presence of an abnormal ECG

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

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

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

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

  16. Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Véronique DIERAS - v.dieras@rennes.unicancer.fr Lucile MORVAN - / Oui 27/08/2018
Afficher les détails
Acronyme : "THOR-Vessie CR108401 2017-002932-18 THOR 42756493BLC3001"
Spécialité : Urologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Cohort 1 (Arm 1A): Erdafitinib
Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).

Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

Experimental: Cohort 2 (Arm 2A): Erdafitinib
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).

Experimental: Cohort 2 (Arm 2B): Pembrolizumab
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

Informations

Carcinomes à cellules transitionnelles de l'urothélium progressifs

 (Des composants mineurs (moins de < 50% [%] au total) de variantes histologiques telles que la différenciation glandulaire ou squameuse, ou l'évolution vers des phénotypes plus agressifs tels que le changement sarcomatoïde ou micropapillaire sont acceptables)

Appareil urinaire

2ième ligne métastatique

Phase: 3

Promoteur: Janssen Research & Development, LLC
Acronymes: THOR-Vessie CR108401
2017-002932-18 THOR
42756493BLC3001
Contact promoteur: Study Contact

Mail promoteur: JNJ.CT@sylogent.com
Tel promoteur: 844-434-4210
Coordonnateur: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

-
Source: Clinical trials.gov le 02/08/2019"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Critères d'inclusion :
  1. "Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than < 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable

  2. Metastatic or surgically unresectable urothelial cancer

  3. Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization

  4. Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)

  5. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)

  6. Participants must meet appropriate molecular eligibility criteria

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

  8. Adequate bone marrow, liver, and renal function"

Critères de non-inclusion :
  1. "Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization

  2. Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured

  3. Symptomatic central nervous system metastases

  4. Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment

  5. Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

  6. Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test

  7. History of uncontrolled cardiovascular disease

  8. Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions"

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 - - / Oui 12/11/2018
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 / Non 17/09/2018
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 : 3475-361 2015-005731-41 keynote 361 keynote-361
Spécialité : Urologie
Traitement : Métastatique 1ere ligne
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Pembrolizumab

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
Intervention: Biological: Pembrolizumab

Experimental: Pembrolizumab+Chemotherapy

Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.

Interventions: Biological: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Gemcitabine

Active Comparator: Chemotherapy

Participants receive EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Interventions: Drug: Cisplatin, Drug: Carboplatin, Drug: Gemcitabine

Informations

Carcinome urothélial

1ière ligne métastatique - Immunothérapie

Phase: 3 a

Promoteur: MSD
Autre(s) acronyme(s): MK3475361 MK3475 361 Keynote 361 keynote-361
Contact promoteur: Contact: Toll Free Number
Mail promoteur: NR
Tel promoteur: 1-888-577-8839
Coordonnateur: Medical Director Merck Sharp & Dohme Corp.

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

Cet essai dans d'autres annuaires :

Titre :

A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma

Critères d'inclusion :

Amendement du 16/04/2018
• La mise à jour du critère d’inclusion n°6 précisant que le tissu pour l’analyse de biomarqueurs doit provenir d’un carcinome urothélial infiltrant ou une biopsie de métastases, provenant de la tumeur initiale ;
• La mise à jour du critère d’inclusion n°7 précisant que les patients ayant une tumeur maligne supplémentaire connue qui progresse ou qui nécessite un traitement actif au cours des 5 dernières années ne peuvent pas être inclus dans l’étude

 

  1. Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter [upper urinary track], bladder, or urethra. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
  2. Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.

  3. Has received no prior systemic chemotherapy for advanced or metastatic urothelial carcinoma, with the following exceptions:

  4. Neoadjuvant platinum-based chemotherapy with recurrence >12 months from completion of therapy is permitted.

  5. Adjuvant platinum-based chemotherapy following radical cystectomy with recurrence >12 months from completion of therapy is permitted.

  6. Has provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.

  7. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.

  8. Demonstrates adequate organ function.

  9. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of pembrolizumab or 180 days after chemotherapy treatment.

  10. Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or 180 days after chemotherapy treatment.

     

    24/04/2017 Amendement étude KEYNOTE-361-Vessie (MK3475-361)

    - L’arrêt de collection des données d’ethnicité et de race.
    - Les nouvelles données de tolérance du pembrolizumab.

     

Critères de non-inclusion :
  1. Has disease that is suitable for local therapy administered with curative intent.

  2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug.

  3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.

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

  5. Has had a prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to the first dose of study drug (6 weeks for nitrosoureas or mitomycin C) or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events (AEs) due to mAbs administered more than 4 weeks earlier.

  6. Has not recovered (i.e., AE ≤ Grade 1 or at Baseline) from AEs due to a previously administered agent.

  7. Has a known additional malignancy that is progressing or requires active treatment.

  8. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.

  9. A history of prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score ≤6; Prostate-specific Antigen (PSA) level undetectable.

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

  11. Has a known history of active tuberculosis (TB).

  12. Has an active infection requiring systemic therapy.

  13. Has a history of severe hypersensitivity reaction (e.g. generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to gemcitabine, carboplatin, or cisplatin or their analogs.

  14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Is a known regular user (including "recreational use") of any illicit drug(s) or had a recent history (within the last year) of drug or alcohol abuse.

  15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy treatment.

  16. Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137).

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

  18. Has known active hepatitis B or hepatitis C.

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 - Sophie Gimenez - s.gimenez@rennes.unicancer.fr / Oui 29/01/2018
Afficher les détails
Acronyme : AAS-Lynch P130937
Spécialité : Digestif
Traitement : Autres traitements exclusifs
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Aspirin300
Acetylsalicylic acid 300 mg tablet by mouth, daily dose during 4 years
Drug: Acetylsalicylic acid lysinate 300 mg
Daily dose during 4 years
Other Name: Aspirin300


Placebo Comparator: Placebo300
Placebo (like Acetylsalicylic acid 300 mg) tablet by mouth, daily dose during 4 years
Drug: Placebo (for Aspirin 300)
Daily dose during 4 years
Other Name: Placebo300


Active Comparator: Aspirin100
Acetylsalicylic acid 100 mg tablet by mouth, daily dose during 4 years
Drug: Acetylsalicylic acid lysinate 100 mg
Daily dose during 4 years
Other Name: Aspirin100


Placebo Comparator: Placebo100
Placebo (like Acetylsalicylic acid 100 mg) tablet by mouth, daily dose during 4 years
Drug: Placebo 100 (for Aspirin 100)
Daily dose during 4 years
Other Name: Placebo100

Informations

Chimioprévention par aspirine sur l’apparition ou la récidive

des adénomes colorectaux (Syndrome de Lynch)

Phase: 3

Promoteur: Assistance Publique - Hôpitaux de Paris
Acronymes: AAS-Lynch
P130937
Contact promoteur: Pr Robert BENAMOUZIG
Amal BOURKEB
Mail promoteur: robert.benamouzig@aphp.fr 
amal.bourkeb@aphp.fr
Source: clinicaltrials 26/01/2018

Cet essai dans d'autres annuaires :

Titre :

Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome

Critères d'inclusion :
  1. Patient with Lynch syndrome bearing an alteration of "mismatch repair" genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria

  2. Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years

  3. Aged less than 75 years

Critères de non-inclusion :
  1. Known allergy to aspirin (including a history of asthma induced by the administration of salicylates or substances with similar activity, including non-steroidal anti-inflammatory)

  2. Need for a prolonged treatment (prevention of cardio-vascular risk) or repeated treatments (recurring migraines) using aspirin or another non-steroidal anti-inflammatory drug (NSAID)

  3. Pregnancy or breast feeding

  4. Participation to another clinical trial during the 12 weeks before inclusion

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 Le Sourd Samuel - Gaëlle Kergoat - g.kergoat@rennes.unicancer.fr / Oui 29/01/2018
Afficher les détails
Acronyme : AG120-C-005 ClarIDHy
Spécialité : Digestif
Traitement : Thérapie ciblée adjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: AG-120 experimental study drug
AG-120, 500mg daily continuous dosing


Placebo Comparator: AG-120 matched placebo
AG-120 matched placebo, daily continuous dosing. Subjects who experience disease progression and were receiving placebo, will be allowed to cross-over and receive AG-120

Informations

CHOLANGIOCARCINOME

avancé non résécable ou métastique

muté IDH1

2ème ou 3ème ligne (dont 5FU ou GMZ)

Phase: 3

Promoteur: Agios Pharmaceuticals, Inc.
Acronymes: AG120-C-005
ClarIDHy
Contact promoteur: Medical Affairs Agios Pharmaceuticals, Inc.
Mail promoteur: Medinfo@agios.com

Tel promoteur: 844-633-2332
-
Clinicaltrials.gov du 06/11/17"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Critères d'inclusion :
  1. Be ≥18 years of age.

  2. Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.

  3. Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested).

  4. Have an ECOG PS score of 0 or 1

  5. Have an expected survival of ≥3 months.

  6. Have at least one evaluable and measurable lesion as defined by RECIST v1.1. Subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.

  7. Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Subjects must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Subjects who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy.

Critères de non-inclusion :
  1. Received a prior IDH inhibitor.

  2. Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed.

  3. Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1.

  4. Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1.

  5. Have known symptomatic brain metastases requiring steroids. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have radiographically stable disease for at least 3 months prior to study entry. Note: up to 10 mg per day of prednisone equivalent will be allowed.

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 Marc Pracht - Aurélie Sauvanet - a.sauvanet@rennes.unicancer.fr / 6 Oui 29/01/2018
Afficher les détails

Fiche détaillée de l'essai