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Trial record 6 of 6 for:    azixa

Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors

This study has been completed.
Information provided by:
Myrexis Inc. Identifier:
First received: October 30, 2006
Last updated: February 11, 2008
Last verified: February 2008
Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.

Condition Intervention Phase
Refractory Solid Tumors Drug: MPC-6827 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Solid Tumors.

Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 1 year ]
  • Pharmacokinetics [ Time Frame: 22 months ]

Secondary Outcome Measures:
  • Antitumor Activity [ Time Frame: 2 years ]

Enrollment: 48
Study Start Date: March 2005
Study Completion Date: February 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MPC-6827
    2-hour intravenous infusion given once weekly for 3 consecutive weeks on a 28 day cycle

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Advanced or Metastatic Cancer
  2. Measurable / Evaluable Disease
  3. Karnofsky score greater than or equal to 70%
  4. Adequate Hematology / Organ function
  5. No Baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

  1. Hypersensitivity to Cremophor EL
  2. Pregnant or Lactating
  3. Spinal Cord Compression
  4. Pre-existing Dementia / Cognitive Disfunction
  5. Require Neupogen or Neulasta to Maintain Neutrophil Count
  6. Have Primary Brain Cancer
  7. Have history of Ischemic Heart Disease
  8. Have Diabetes
  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: NCT00394446

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: Margaret Yu, MD Myrexis Inc.
  More Information

Responsible Party: Margaret Yu, MD / Director of Clinical Research, Myriad Pharmaceuticals, Inc. Identifier: NCT00394446     History of Changes
Other Study ID Numbers: MPC6827-04-001
Study First Received: October 30, 2006
Last Updated: February 11, 2008

Keywords provided by Myrexis Inc.:
Solid Tumors
Brain processed this record on September 21, 2017