Spots Global Cancer Trial Database for Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma
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Trial Identification
Brief Title: Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma
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
Study ID: NCT01614301
Conditions
Study Description
Brief 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Regensburg, Regensburg, Bavaria, Germany
Contact Details
Name: Albrecht Reichle, Professor
Affiliation: University of Regensburg
Role: PRINCIPAL_INVESTIGATOR
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