Endometrial metastatic cancer MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: RAD001
Pharmaceutical Form: Tablet
Sponsors
ARCAGY-GINECO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with an histologically proven diagnosis of endometrial cancer Patients with metastatic disease after a first or a second chemotherapy line Patients should have previously received a platinum-based treatment at adjuvant or metastatic stage Patients with metastatic target lesions in non-irradiated zones Patients with ECOG performance statut under or equal to 2 and adequate bone marrow function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have previously received experimental drugs (mTOR inhibitor) Patients with local tumor relapse accessible by surgical treatment Presence of medically uncontrolled brain metastases Patients with prior diagnosis of malignancy except in situ cervix carcinoma or adequately treated and cured basal or spinal cell skin carcinoma, or other previous carcinoma diagnosed and cured more than 3 years before inclusion High grade pneumonitis Anti-vitamin K treatment Patients with known hypersensitivity to everolimus or sirolimus (rapamycin) or lactosis (contained in RAD001 formulations) Demencia or significantly altered mental status that could alter patient's compliance or understanding of informed consent discussion Patients with an history of non-compliance to medical treatment Administration, simultaneously or within the last 21 days, of another chemotherapy, or hormonotherapy, or any anti-tumoral drugs Patients who have previously received molecules known to be iso-enzymes CYP3A stong inhibitors or inductors, within the last 5 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Tumoral response and tumoral progression assessment according to RECIST criteria Toxicities assessment according to CTCAE version 3.0 Study analysis done in different steps : - recruitment goal of 44 patients - when 19 assessable patients are in (eligible and treated during at least one month), if less than 4 successes (response or stabilisation) are observed, the enrolment will be stopped for non-sufficient efficacy of Everolimus treatment - otherwise, enrolment will be continued until 44 assessable patients. If more than 11 successes are obtained we will conclude that Everolimus is interesting enough to justify further studies.;Main Objective: Non-progression rate after 3 months of treatment;Secondary Objective: Response rate after 3 months of treatment, response duration, clinical benefits after 6 months of treatment; time to progression, progression-free survival and overall survival; toxicities type, severity and frequency; P-TEN mutations analysis on tumor blocs (in a majority of centres) | — |
Countries
France
Outcome results
None listed