NCT00609011

Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma

Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Myrexis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	MPC-6827 + Temozolomide	MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Temozolomide at 85 mg/m2 administered orally daily for 21 days in a 4 week cycle.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-02-06
• Last updated: 2010-08-23

Locations

5 sites across 1 country: United States