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

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00920205
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-13
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability (Maximum Tolerated Dose)	After each cohort is enrolled .

Secondary Outcome Measures

Name	Time	Method
Study Drug Pharmacokinetics	Cycle 1
Evidence of anti-tumor activity of study drug.	After each odd cycle and end of study.

Trial Locations

Locations (3)

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States