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

NCT00920205 | Completed Phase 1

• 1 other identifier: MPC-3100-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

MPC-3100; HSP90 inhibitor; oral drug; cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability (Maximum Tolerated Dose)

  After each cohort is enrolled .

Secondary Outcomes (2)

• Study Drug Pharmacokinetics

  Cycle 1

• Evidence of anti-tumor activity of study drug.

  After each odd cycle and end of study.

Interventions

MPC-3100 (an Hsp90 inhibitor) DRUG

oral daily dose for 21 days in a 28-day cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recurrent cancer refractory to available systemic therapy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (3)

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

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

  PMID: 15299085 BACKGROUND

• 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. doi: 10.1517/14712598.2.1.3.

  PMID: 11772336 BACKGROUND

Related 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.

MeSH Terms

Conditions

Neoplasms

Interventions

1-(4-(2-(6-amino-8-((6-bromo-1,3-benzodioxol-5-yl)sulfanyl)-9H-purin-9-yl)ethyl)piperidin-1-yl)-2-hydroxypropan-1-one

Study Officials

• Andrew Beelen, MD

  Myrexis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (3)