NCT00714025

A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single arm, non-randomized, single stage phase II study. 3 phases:Baseline, treatment/duration and Follow-up. All patients will be treated with RAD001 10 mg daily dose until disease progression or unacceptable toxicity death, or discontinuation from the study, for any other reason

Detailed description

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.

Conditions

• Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	RAD001	RAD001 10mg, daily, PO

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2012-01-01
• First posted: 2008-07-14
• Last updated: 2012-01-24

Locations

1 site across 1 country: Belgium