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Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
This study has been completed.
Sponsored by: Myriad Pharmaceuticals
Information provided by: Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00393965
  Purpose

Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.


Condition Intervention Phase
Brain Neoplasms
 Drug: MPC-6827
 Phase I

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title: Phase 1 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 Brain Metastases

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: 1 year ] [ Designated as safety issue: No ]

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

Enrollment: 18
Study Start Date: December 2005
Study Completion Date: February 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MPC-6827
    2-hour IV 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:

  • Refractory Brain Metastases
  • At least 1 measurable intracranial lesion as defined by RECIST
  • ECOG less than or equal to 1
  • Adequate hematology/organ function
  • No baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

  • Hypersensitivity to Cremophor EL
  • Pregnant or Lactating
  • Spinal Cord Compression
  • Pre-existing dementia/cognitive disfunction
  • Require Neupogen or Neulasta to Maintain Neutrophil Count
  • Have Primary Brain Cancer
  • Have History of Ischemic Heart Disease
  • Have Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393965

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
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: MPC-6827-04-002
Study First Received: October 30, 2006
Last Updated: February 11, 2008
ClinicalTrials.gov Identifier: NCT00393965  
Health Authority: United States: Food and Drug Administration

Keywords provided by Myriad Pharmaceuticals:
Metastases
Refractory
Brain

Study placed in the following topic categories:
Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases
 Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009



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