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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Refractory Solid Tumors

Thank you

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 CenterHouston, Texas  77030
Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah  84112