A single arm, multicenter, phase II trial of RAD001 as monotherapy in the palliative treatment of patient with locally advanced or metastatic transitional cell carcinoma after failure of platinum-based chemotherapy
- Conditions
- Palliative patients with locally advanced or metastatic transitional cell carcinoma after failure of platinum-based chemotherapy
- Registration Number
- EUCTR2008-004575-21-BE
- Lead Sponsor
- Cliniques Universitaires St Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>- 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
- Secondary Outcome Measures
Name Time Method