This trial is active, not recruiting.

Condition glioblastoma multiforme
Treatment mpc-6827 + carboplatin
Phase phase 1/phase 2
Sponsor Myrexis Inc.
Start date March 2008
End date October 2010
Trial size 30 participants
Trial identifier NCT00635557, MPC-6827 GBM, MPC-6827-07-004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Maximum tolerated dose
time frame: After each cohort is enrolled and all subjects have completed 1 cycle

Secondary Outcomes

time frame: Cycle 1 only
Antitumor activity
time frame: Screening, end of each cycle, end of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Myrexis Inc..