Trial Information
Phase I 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 Solid Tumors.
Inclusion Criteria:
1. Advanced or Metastatic Cancer
2. Measurable / Evaluable Disease
3. Karnofsky score greater than or equal to 70%
4. Adequate Hematology / Organ function
5. No Baseline peripheral or central neuropathy above grade 1
Exclusion Criteria:
1. Hypersensitivity to Cremophor EL
2. Pregnant or Lactating
3. Spinal Cord Compression
4. Pre-existing Dementia / Cognitive Disfunction
5. Require Neupogen or Neulasta to Maintain Neutrophil Count
6. Have Primary Brain Cancer
7. Have history of Ischemic Heart Disease
8. 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:
MPC6827-04-001
NCT ID:
NCT00394446
Start Date:
March 2005
Completion Date:
February 2008
Related Keywords:
- Refractory Solid Tumors
- Solid Tumors
- Refractory
- Brain
- Neoplasms
Name | Location |
University of Texas MD Anderson Cancer Center |
Houston, Texas 77030 |
Huntsman Cancer Institute at the University of Utah |
Salt Lake City, Utah 84112 |