ARQ 501 in Subjects With Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

January 12, 2004

Last Updated Date

April 27, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00075933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

ARQ 501 in Subjects With Cancer

Official Title ^ICMJE

A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: ARQ 501

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00075933

Responsible Party

Study ID Numbers ^ICMJE

ARQ 501-101

Study Sponsor ^ICMJE

ArQule

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

ArQule

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP