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

Cancer

Intervention / Treatment

Drug: MPC-3100 (an Hsp90 inhibitor)

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)

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

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

Myriad Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection.

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)