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

NCT ID: NCT00609011

Last Updated: 2010-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-08-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven melanoma
• For subjects with brain metastases that require radiation, therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug
• Have unresectable melanoma with measurable metastases
• Be a minimum of 4 weeks since prior surgical resection or major surgical procedure and a minimum of 2 weeks since chemotherapy/ biochemotherapy
• Performance score of Karnofsky ≥ 60%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2, or WHO ≤ 2
• If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria

• Hypersensitivity to Cremophor EL
• Have current/active intratumor hemorrhage by CT/MRI within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI
• Have ocular melanoma
• Have primary intradural melanoma or leptomeningeal involvement
• Have cardiovascular disease (unstable angina or MI)
• Have cerebrovascular disease (stroke and/or TIA)
• Have uncontrolled hypertension
• Have a cardiac ejection fraction < 50%
• Have Troponin-I elevated above the normal range

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Myrexis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Myriad Pharmaceuticals

Principal Investigators

Andrew P. Beelen, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

The Angeles Clinic

Los Angeles, California, United States

Cancer Centers of Florida

Ocoee, Florida, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

MPC-6827-07-005

Identifier Type: -

Identifier Source: org_study_id