Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors

Phase 1

Completed

• Conditions: Refractory Solid Tumors

• Registration Number: NCT00394446
• Lead Sponsor: Myrexis Inc.

Brief Summary

Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-01
• Primary Completion: 2007-04
• Status Verified: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-11
• Last Update Posted: 2008-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	1 year
Pharmacokinetics	22 months

Secondary Outcome Measures

Name	Time	Method
Antitumor Activity	2 years

Trial Locations

Locations (2)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah; 🇺🇸 Salt Lake City, Utah, United States