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

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ClinicalTrials.gov Identifier: NCT00393965
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : February 13, 2008
Sponsor:
Information provided by:
Myrexis Inc.

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

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: MPC-6827 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : February 2008

Intervention Details:
  • Drug: MPC-6827
    2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.


Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 1 year ]
  2. Pharmacokinetics [ Time Frame: 1 year ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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.

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
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: February 2008

Keywords provided by Myrexis Inc.:
Metastases
Refractory
Brain

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