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

NCT ID: NCT00393965

Last Updated: 2008-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-02-29

Brief Summary

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

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MPC-6827

2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Myrexis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Myriad Pharmaceuticals, Inc.

Principal Investigators

Margaret Yu, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MPC-6827-04-002

Identifier Type: -

Identifier Source: org_study_id