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

NCT00635557 | Unknown Phase 1

• 2 other identifiers: MPC-6827-07-004MPC-6827 GBM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

Recurrent; Relapsed; Glioblastoma; Multiforme

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  After each cohort is enrolled and all subjects have completed 1 cycle

Secondary Outcomes (2)

• Pharmacokinetics

  Cycle 1 only

• Antitumor activity

  Screening, end of each cycle, end of study

Interventions

MPC-6827 + Carboplatin DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (5)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

verubulin; Carboplatin

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Andrew P. Beelen, MD

  Myrexis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2011
• Last Updated: March 25, 2011

Record last verified: 2011-03

Locations

US (5)