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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2016

Conditions
Advanced Melanoma
Interventions
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"

Trial Locations (1)

93053

RECRUITING

University of Regensburg, Regensburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ClinAssess GmbH

INDUSTRY

lead

University of Regensburg

OTHER

NCT01614301 - Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma | Biotech Hunter | Biotech Hunter