COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609011
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : August 23, 2010
Information provided by:
Myrexis Inc.

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: MPC-6827 + Temozolomide Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.

Primary Outcome Measures :
  1. Safety and Tolerability; Maximum Tolerated Dose [ Time Frame: After each cohort is enrolled ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Cycle 1 ]
  2. Antitumor Activity [ Time Frame: Screening, end of each cycle, end of study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609011

Layout table for location information
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.
Layout table for investigator information
Study Director: Andrew P. Beelen, MD Myrexis Inc.
Layout table for additonal information
Responsible Party: Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myriad Pharmaceuticals Identifier: NCT00609011    
Other Study ID Numbers: MPC-6827-07-005
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: August 2010
Keywords provided by Myrexis Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents