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Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments

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: NCT00920205
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : October 14, 2011
Sponsor:
Information provided by (Responsible Party):
Myrexis Inc.

Tracking Information
First Submitted Date  ICMJE June 12, 2009
First Posted Date  ICMJE June 15, 2009
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
Safety and Tolerability (Maximum Tolerated Dose) [ Time Frame: After each cohort is enrolled . ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • Study Drug Pharmacokinetics [ Time Frame: Cycle 1 ]
  • Evidence of anti-tumor activity of study drug. [ Time Frame: After each odd cycle and 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 Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments
Official Title  ICMJE Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
Brief Summary

The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future.

The study drug is designed to reduce the activity of a protein known as "heat shock protein 90", or "Hsp90". Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.

Detailed Description This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Cancer
Intervention  ICMJE Drug: MPC-3100 (an Hsp90 inhibitor)
oral daily dose for 21 days in a 28-day cycle
Study Arms  ICMJE Not Provided
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2009)
40
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • recurrent cancer refractory to available systemic therapy
  • 18 years old or older
  • predicted life expectancy equal or greater to 8 weeks
  • at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
  • Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
  • adequate organ function based on hematological, liver, and renal function
  • LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
  • wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued

Exclusion Criteria:

  • pregnant or breastfeeding
  • received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
  • symptoms of heart failure equal or greater to Class III (by NYHA criteria)
  • impaired cardiac function or clinically significant cardiac diseases
  • concurrent treatment with medications that either markedly induce or inhibit CYP3A4
  • concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug
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 NCT00920205
Other Study ID Numbers  ICMJE MPC-3100-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Myrexis Inc.
Original Responsible Party Margaret Yu, Director of Clinical Research, Myriad Pharmaceuticals
Current Study Sponsor  ICMJE Myrexis Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Beelen, MD Myrexis Inc.
PRS Account Myrexis Inc.
Verification Date October 2011

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