Palliative patients with locally advanced or metastatic transitional cell carcinoma after failure of platinum-based chemotherapy
Conditions
Sponsors
Cliniques Universitaires St Luc
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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 | — |
Countries
Belgium, France
Outcome results
None listed