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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01614301
Study type Interventional
Source University of Regensburg
Contact
Status Recruiting
Phase Phase 1/Phase 2
Start date May 2012
Completion date May 2016

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