E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Palliative patients with locally advanced or metastatic transitional cell carcinoma after failure of platinum-based chemotherapy |
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MedDRA Classification |
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 |
To evaluate the efficacy and safety of RAD001 for the treatment of patients with locally advanced or metastatic transitional cell carcinoma progressing after platinum-based therapy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the response rate, duration of response, progression-free survival and overall survival in this patient population, and to further characterize the safety profile of RAD001. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients histologically- orcytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation - Patient with documented disease progression after first-line platinum -based therapy - Patients with at least one measurable lesion as at baseline as per RECIST criteria - ECOG performance status of 0-2 - Patients must be over 18 years old and must be able to give written informed consent - Patients with adequate bone marrow function, liver function and renal function - Patients must have an expected survival of at least 6 months
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E.4 | Principal exclusion criteria |
- Patients who have received more than 2 systemic treatment for their metastatic disease - Patients who received prior therapy with VEGF pathway inhibitor or other biological therapies at the exception of mTOR inhibitors - Patients who have previously received mTOR inhibitors - Patients with a known hypersensibility to RAD001 or other rapamycins or to its excipients - Patients with brain or leptomeningeal metastases - Patients receiving chronic systemic treatment with corticosteroïds or another immunosuppressive agent - Patients with known hitory of HIV seropositivity - Patients with an active, bleeding diathesis - Patients who have any severe and/or uncotrolled medical conditions or other conditions that could affect their participation in the study - Patients who have a history of another primary malignancy more than 5 years ago
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E.5 End points |
E.5.1 | Primary end point(s) |
-Determine the efficacy of RAD001 alone in patients with TCC progression (SD+PR+CR) - Determine the safety of RAD001 alone in patients with TCC progression (incidence of adverse events, serious adverse events, changes from baseline in vital signs and laboratory results |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 10 |
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
|
End of the study occurs at the last patient's last visit |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |