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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609011
First Posted: February 6, 2008
Last Update Posted: August 23, 2010
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.
Information provided by:
Myrexis Inc.
  Purpose
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
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

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 ]

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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00609011


Locations
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.
Investigators
Study Director: Andrew P. Beelen, MD Myrexis Inc.
  More Information

Responsible Party: Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00609011     History of Changes
Other Study ID Numbers: MPC-6827-07-005
First Submitted: January 23, 2008
First Posted: February 6, 2008
Last Update Posted: August 23, 2010
Last Verified: August 2010

Keywords provided by Myrexis Inc.:
Melanoma
Metastatic

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents