NCT01614301

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus	Dacarbazine (DTIC) 1000 mg/m2 day 1, every 3 weeks The total number of DTIC cycles should not exceed 6 cycles due to cumulative toxicity. Temsirolimus: 15 or 25 mg iv weekly , week 1+.In the phase I part of the study the finally used dosis will be determined. Pioglitazone (Actos) 60 mg p.o. daily, day 1+. Etoricoxib (Arcoxia) 60 mg p.o. daily, day 1+. Trofosfamide (Ixoten) 50 mg p.o. thrice daily as metronomic angiostatically and immunomodulatory actingtherapy, day 1+. Treatment until disease progression or toxicity

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2016-05-01
• First posted: 2012-06-07
• Last updated: 2012-06-07

Locations

1 site across 1 country: Germany