Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases

Phase 1

Completed

• Conditions: Brain Neoplasms

• Registration Number: NCT00393965
• Lead Sponsor: Myrexis Inc.

Brief Summary

Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-10-31
• Primary Completion: 2007-08
• 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: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	1 year
Pharmacokinetics	1 year

Secondary Outcome Measures

Name	Time	Method
Antitumor Activity	2 years

Trial Locations

Locations (1)

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