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

This study is currently recruiting participants.

Verified by Myriad Pharmaceuticals, June 2009

First Received: March 6, 2008 Last Updated: June 16, 2009 History of Changes

Sponsored by:	Myriad Pharmaceuticals
Information provided by:	Myriad Pharmaceuticals
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:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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 Myriad Pharmaceuticals:

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:	October 2009
Estimated Primary Completion Date:	October 2009 (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

Contacts

Contact: Cathy Pope, RN, BSN	801-214-7899	cathy.pope@myriadpharma.com
Contact: Margaret Yu, MD	801-214-7824	margaret.yu@myriadpharma.com

Locations

United States, California
The Angeles Clinic and Research Institute	Recruiting
Los Angeles, California, United States, 90025
Contact: Brenda Fulham 310-231-2184
Principal Investigator: Omid Hamid, MD
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Jeffrey Olson, MD
United States, New York
Mt. Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Principal Investigator: Robert Aiken, MD
United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: John DeGroot, MD
United States, Utah
Huntsman Cancer Institute at the University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Wallace Akerley, MD

Sponsors and Collaborators

Myriad Pharmaceuticals

Investigators

Study Director:

Margaret Yu, MD

Myriad Pharmaceuticals

More Information

No publications provided

Responsible Party:	Myriad Pharmaceuticals ( Margaret Yu, MD / Director of Clinical Research )
Study ID Numbers:	MPC-6827-07-004, MPC-6827 GBM
Study First Received:	March 6, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00635557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Myriad Pharmaceuticals:

Recurrent
Relapsed
Glioblastoma
Multiforme

Study placed in the following topic categories:

Neuroectodermal Tumors
Signs and Symptoms
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Carboplatin
Glioblastoma Multiforme
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carboplatin
Pharmacologic Actions

Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009