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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00920205
First received: June 12, 2009
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: MPC-3100 (an Hsp90 inhibitor)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Safety and Tolerability (Maximum Tolerated Dose) [ Time Frame: After each cohort is enrolled . ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Study Drug Pharmacokinetics [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
  • Evidence of anti-tumor activity of study drug. [ Time Frame: After each odd cycle and end of study. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MPC-3100 (an Hsp90 inhibitor)
    oral daily dose for 21 days in a 28-day cycle
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920205

Locations
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Andrew Beelen, MD Myrexis Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Myrexis Inc.
ClinicalTrials.gov Identifier: NCT00920205     History of Changes
Other Study ID Numbers: MPC-3100-001
Study First Received: June 12, 2009
Last Updated: October 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Myrexis Inc.:
MPC-3100
HSP90 inhibitor
oral drug
cancer

ClinicalTrials.gov processed this record on August 25, 2014