Status:
COMPLETED
Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Lead Sponsor:
Myrexis Inc.
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 end...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00609011
Start Date
March 1 2008
End Date
August 1 2009
Last Update
August 23 2010
Active Locations (5)
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1
The Angeles Clinic
Los Angeles, California, United States, 90025
2
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
3
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030