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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Margaret Yu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-6827-04-002

NCT ID:

NCT00393965

Start Date:

December 2005

Completion Date:

February 2008

Related Keywords:

  • Brain Neoplasms
  • Metastases
  • Refractory
  • Brain
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096