ARQ 501 in Subjects With Cancer - Full Text View

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

Genetics Home Reference related topics:

Benign Tumors Cancer

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

beta-Lapachone

U.S. FDA Resources

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

Further study details as provided by ArQule:

Estimated Enrollment:	80
Study Start Date:	September 2003
Estimated Study Completion Date:	January 2007
Estimated 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

Study ID Numbers:	ARQ 501-101
First Received:	January 12, 2004
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00075933
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Beta-lapachone

ClinicalTrials.gov processed this record on July 03, 2008

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