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

March 24, 2011 updated by: Myrexis Inc.

Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at The University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose
Time Frame: After each cohort is enrolled and all subjects have completed 1 cycle
After each cohort is enrolled and all subjects have completed 1 cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: Cycle 1 only
Cycle 1 only
Antitumor activity
Time Frame: Screening, end of each cycle, end of study
Screening, end of each cycle, end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myrexis Inc.

Investigators

  • Study Director: Andrew P. Beelen, MD, Myrexis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2011

Last Update Submitted That Met QC Criteria

March 24, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-6827-07-004
  • MPC-6827 GBM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on MPC-6827 + Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe