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Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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MPC-6827-07-005
NCT00609011
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Trial Description
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. 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 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
Trial Contact Information
Trial Lead Organizations/Sponsors Myriad Pharmaceuticals, Incorporated | Margaret Yu, MD | | Study Director |
Trial Sites
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| U.S.A. |
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| California |
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Los Angeles |
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| | | | | | | | | Angeles Clinic and Research Institute - Los Angeles |
| | | Omid Hamid, MD | Principal Investigator |
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| Texas |
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Houston |
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| | | | M. D. Anderson Cancer Center at University of Texas |
| | | Wen Jen Hwu, MD | Principal Investigator |
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| Utah |
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Salt Lake City |
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| | | | Huntsman Cancer Institute at University of Utah |
| | | Wallace Akerley, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00609011
Information obtained from ClinicalTrials.gov on September 09, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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