Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma

Summary

A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma Phase I: To determine the dose of temsirolimus to be used in phase II part of the study Phase II: To determine overall survival Secondary objectives * To evalulate response rate * To evaluate time to progression (TTP) * To evalulate time to partial response (time to PR or better)(TPR) * To evaluate quality of life * To evaluate tolerability and safety

Timeline

Start

2012-05

Primary completion

2014-05

Completion

2016-05

Drugs

Indications