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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00635557
• Other study ID #: MPC-6827-07-004
• Secondary ID: MPC-6827 GBM
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 6, 2008
• Last updated: March 24, 2011
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• MPC-6827 + Carboplatin
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	Mt. Sinai School of Medicine	New York	New York
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		After each cohort is enrolled and all subjects have completed 1 cycle	Yes
Secondary	Pharmacokinetics		Cycle 1 only	No
Secondary	Antitumor activity		Screening, end of each cycle, end of study	No