Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer

Phase 2 Completed 54 enrolled Institut Bergonié Wyeth is now a wholly owned subsidiary of Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.

Timeline

Start: 2009-06
Primary completion: 2014-12
Completion: 2016-12

Outcome

Met primary endpoint

paper A total of 22 (48.9%) non-progressions were observed at 2 months with 3 partial responses and 19 stable diseases. PMID 29454321 ↗

paper This led to recruitment being halted by an independent data monitoring committee with regard to the risk-benefit balance and the fact that the primary objective was already met. PMID 29454321 ↗

Publications

Results Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houede N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temsirolimus	Small molecule	25 mg	Intravenous