ARQ 501 in Subjects With Cancer

This study has been completed.

First Received: January 12, 2004 Last Updated: April 27, 2009 History of Changes

Sponsored by:	ArQule
Information provided by:	ArQule
ClinicalTrials.gov Identifier:	NCT00075933

Purpose

ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).

ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.

Condition	Intervention	Phase
Cancer	Drug: ARQ 501	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: beta-Lapachone

U.S. FDA Resources

Further study details as provided by ArQule:

Estimated Enrollment:	80
Study Start Date:	September 2003
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.
ECOG performance status greater than or equal to 1
Life expectancy greater than three months
Acceptable pretreatment clinical laboratory results

Exclusion Criteria

Subjects who have had chemotherapy or radiotherapy within 4 weeks
Subjects receiving any other investigational agents
Subjects with known untreated brain metastases
Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")
Subjects with uncontrolled intercurrent illnesses
Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075933

Locations

United States, Massachusetts
Dana Farber/Partners CancerCare Inc
Boston, Massachusetts, United States, 02115
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201

Sponsors and Collaborators

ArQule

Investigators

Principal Investigator:	Geoffrey I Shapiro, MD	Dana-Farber Cancer Institute
Principal Investigator:	C. Casey Cunningham, MD	Mary Crowley Medical Research Center

More Information

No publications provided

Study ID Numbers:	ARQ 501-101
Study First Received:	January 12, 2004
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00075933 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Retroviral Agents
Radiation-Sensitizing Agents
Beta-lapachone
Antiviral Agents
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Beta-lapachone
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009