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Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors
This study has been completed.
Sponsored by: Myriad Pharmaceuticals
Information provided by: Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00394446
  Purpose

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


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

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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 Myriad Pharmaceuticals:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor Activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394446

Locations
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
Myriad Pharmaceuticals
Investigators
Study Director: Margaret Yu, MD Myriad Pharmaceuticals
  More Information

Responsible Party: Myriad Pharmaceuticals, Inc. ( Margaret Yu, MD / Director of Clinical Research )
Study ID Numbers: MPC6827-04-001
Study First Received: October 30, 2006
Last Updated: February 11, 2008
ClinicalTrials.gov Identifier: NCT00394446  
Health Authority: United States: Food and Drug Administration

Keywords provided by Myriad Pharmaceuticals:
Solid Tumors
Refractory
Brain

ClinicalTrials.gov processed this record on January 16, 2009



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