Advanced Melanoma Clinical Trial
Official title:
A Prospective Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial of Temsirolimus in Combination With Pioglitazone, Etoricoxib and Metronomic Low-dose Trofosfamide Versus Dacarbazine (DTIC) in Patients With Advanced Melanoma
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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