A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma After Failure of Platinum-based Chemotherapy
An open-label, single arm, non-randomized, single stage phase II study. Baseline phase:
Baseline evaluations will be performed within 2 weeks before the first dose study drug.
Treatment phase/duration of treatment: All patients will be treated with RAD001 10mg PO
daily dose until disease progression (by RECIST) or unacceptable toxicity death or
discontinuation from the study for any other reason.
Follow-up phase: All patients will have a follow-up visit scheduled 28 days after the last
dose of the study drug to follow for AEs and SAEs that may have occured after
discontinuation from the study. Any patient who is discontinued from treatment with RAD001
for any reason other than disease progression will continue to have tumor assessments until
the patient has documented disease progression or start of additional anti-tumor therapy.
Central radiology review and survival data collection will be performed. After
discontinuation of RAD001 all patients will be followed up for survival until the final OS
analysis is performed.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary:To evaluate the preliminary efficacy of RAD001 as monotherapy for the treatment of locally advanced or metastatic TCC. Efficacy is defined as the disease control rate at 8 weeks.
Jean-Pascal H Machiels, MD PhD
Cliniques Universitaires St Luc-UCL
Belgium: Federal Agency for Medicinal Products and Health Products