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

NCT01614301 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2012-06-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Albrecht Reichle, Professor · University of Regensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614301 on ClinicalTrials.gov