A multicentre phase II study, estimating the efficiency and the tolerance of RAD001 (Everolimus) , in patients with endometrial metastatic cancer resistant to a first line of chemotherapy - ENDORAD

• Conditions: Endometrial metastatic cancer; MedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-003002-10-FR
• Lead Sponsor: ARCAGY-GINECO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified