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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920205
• Other study ID #: MPC-3100-001
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2009
• Last updated: October 13, 2011
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2011
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability (Maximum Tolerated Dose)		After each cohort is enrolled .	Yes
Secondary	Study Drug Pharmacokinetics		Cycle 1	No
Secondary	Evidence of anti-tumor activity of study drug.		After each odd cycle and end of study.	No