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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00635557
Recruitment Status : Unknown
Verified March 2011 by Myrexis Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2008
Last Update Posted : March 25, 2011
Sponsor:
Information provided by:
Myrexis Inc.

Tracking Information
First Submitted Date  ICMJE March 6, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date March 25, 2011
Study Start Date  ICMJE March 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Maximum tolerated dose [ Time Frame: After each cohort is enrolled and all subjects have completed 1 cycle ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • Pharmacokinetics [ Time Frame: Cycle 1 only ]
  • Antitumor activity [ Time Frame: Screening, end of each cycle, end of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Official Title  ICMJE Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 6, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635557
Other Study ID Numbers  ICMJE MPC-6827-07-004
MPC-6827 GBM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myrexis Inc.
Study Sponsor  ICMJE Myrexis Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew P. Beelen, MD Myrexis Inc.
PRS Account Myrexis Inc.
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP