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

This study has been completed.
Information provided by:
Myrexis Inc. Identifier:
First received: January 23, 2008
Last updated: August 19, 2010
Last verified: August 2010
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.

Condition Intervention Phase
Metastatic Melanoma
Drug: MPC-6827 + Temozolomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide

Resource links provided by NLM:

Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Safety and Tolerability; Maximum Tolerated Dose [ Time Frame: After each cohort is enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
  • Antitumor Activity [ Time Frame: Screening, end of each cycle, end of study ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: March 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00609011

United States, California
The Angeles Clinic
Los Angeles, California, United States, 90025
United States, Florida
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Myrexis Inc.
Study Director: Andrew P. Beelen, MD Myrexis Inc.
  More Information

Responsible Party: Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myriad Pharmaceuticals Identifier: NCT00609011     History of Changes
Other Study ID Numbers: MPC-6827-07-005 
Study First Received: January 23, 2008
Last Updated: August 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2016