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

October 13, 2011 updated by: Myrexis Inc.

Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability (Maximum Tolerated Dose)
Time Frame: After each cohort is enrolled .
After each cohort is enrolled .

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myrexis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MPC-3100-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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