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
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms
Both
Brain Neoplasms
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 Center | Houston, Texas 77030-4096 |
