Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme

Phase 1

• Conditions: Glioblastoma Multiforme

• Registration Number: NCT00635557
• Lead Sponsor: Myrexis Inc.

Brief Summary

This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Primary Completion: 2010-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-24
• Last Update Posted: 2011-03-25
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
• Prior treatment with radiotherapy and temozolomide
• Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
• Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
• Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
• If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria

• Hypersensitivity to Cremophor EL
• Have evidence of current/active intratumor hemorrhage by MRI
• Have greater than second relapse
• Have had prior treatment with platinum-based chemotherapy
• Have cardiovascular disease
• Have cerebrovascular disease
• Have uncontrolled hypertension
• Have a cardiac ejection fraction < 50%
• Have Troponin-I elevated above the normal range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	After each cohort is enrolled and all subjects have completed 1 cycle

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	Cycle 1 only
Antitumor activity	Screening, end of each cycle, end of study

Trial Locations

Locations (5)

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

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

Mt. Sinai School of Medicine; 🇺🇸 New York, New York, United States

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