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

Sponsor:	Myrexis Inc.
Information provided by (Responsible Party):	Myrexis Inc.
ClinicalTrials.gov Identifier:	NCT00920205

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 I

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:

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

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:

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Bagatell R, Whitesell L. Altered Hsp90 function in cancer: a unique therapeutic opportunity. Mol Cancer Ther. 2004 Aug;3(8):1021-30. Review.

Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. Review.

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 February 07, 2012