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

NCT ID: NCT00920205

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MPC-3100 (an Hsp90 inhibitor)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Myrexis Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew Beelen, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 15299085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11772336 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.myriadpharma.com

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.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MPC-3100-001

Identifier Type: -

Identifier Source: org_study_id