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

Sponsor:	Myrexis Inc.
Information provided by:	Myrexis Inc.
ClinicalTrials.gov Identifier:	NCT00635557

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.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: MPC-6827 + Carboplatin	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: After each cohort is enrolled and all subjects have completed 1 cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Cycle 1 only ] [ Designated as safety issue: No ]
Antitumor activity [ Time Frame: Screening, end of each cycle, end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635557

Locations

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

Sponsors and Collaborators

Myrexis Inc.

Investigators

Study Director:

Andrew P. Beelen, MD

Myrexis Inc.

More Information

No publications provided

Responsible Party:	Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myrexis Inc.
ClinicalTrials.gov Identifier:	NCT00635557 History of Changes
Other Study ID Numbers:	MPC-6827-07-004, MPC-6827 GBM
Study First Received:	March 6, 2008
Last Updated:	March 24, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:

Recurrent
Relapsed
Glioblastoma
Multiforme

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type

Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2012