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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00635557
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Myrexis Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew P. Beelen, MD
Principal Investigator Affiliation Myrexis Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

Emory University, Atlanta, Georgia

Status

Address

Emory University

Atlanta, Georgia, 30322

Mt. Sinai School of Medicine, New York, New York

Status

Address

Mt. Sinai School of Medicine

New York, New York, 10029

Houston, Texas

Status

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112

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