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Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases

This study has been completed.
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00393965
First received: October 30, 2006
Last updated: February 11, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Brain Neoplasms
 Drug: MPC-6827
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by Myrexis Inc.:

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
Myrexis Inc.
Investigators
Study Director: Margaret Yu, MD Myrexis Inc.
  More Information

No publications provided

Responsible Party: Margaret Yu, MD / Director of Clinical Research, Myriad Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00393965     History of Changes
Other Study ID Numbers: MPC-6827-04-002
Study First Received: October 30, 2006
Last Updated: February 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Metastases
Refractory
Brain

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013