E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Endometrial metastatic cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Non-progression rate after 3 months of treatment |
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E.2.2 | Secondary objectives of the trial |
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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
prognosis role of T-PEN mutations |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study end will occur at the time when the three below criteria will be gathered : - At least 30 days after all patients have stopped study treatment (median of 4 months, but possible continuation until progression) - When the study is mature for the primary objective analysis, such as defined in the protocol - When the data base is completely cleaned and frozen for this analysis
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |