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

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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.

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.


Condition or disease Intervention/treatment Phase
Cancer Drug: MPC-3100 (an Hsp90 inhibitor) Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Intervention Details:
    Drug: MPC-3100 (an Hsp90 inhibitor)
    oral daily dose for 21 days in a 28-day cycle


Primary Outcome Measures :
  1. Safety and Tolerability (Maximum Tolerated Dose) [ Time Frame: After each cohort is enrolled . ]

Secondary Outcome Measures :
  1. Study Drug Pharmacokinetics [ Time Frame: Cycle 1 ]
  2. Evidence of anti-tumor activity of study drug. [ Time Frame: After each odd cycle and end of study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications:
Responsible Party: Myrexis Inc.
ClinicalTrials.gov Identifier: NCT00920205     History of Changes
Other Study ID Numbers: MPC-3100-001
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011

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