Trial intelligence / Profile preview

BEZ235 in Advanced TCC

NCT01856101Phase 2

Key facts

Status
Terminated
Start
Feb 2013
Primary completion
Jan 2014
Countries
2
Modality
Small Molecules
Conditions
transitional cell carcinoma (TCC)
01

Overview

Phase 2, open-label, single-arm trial of dactolisib in transitional cell carcinoma (TCC). Primary endpoint: Disease Control Rate at 16 weeks. Started Feb 2013; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • BEZ235

    Patients receive BEZ235 (dactolisib) monotherapy.

03

Who it enrols

Patients with locally advanced or metastatic TCC who have progressed after first-line platinum-based therapy, with adequate organ function and no prior PI3K/mTOR inhibitor treatment.

04

Endpoints

Primary

  • Disease Control Rate

Secondary

  • Safety Profile

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