ARQ 501 in Subjects With Cancer - Tabular View

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ARQ 501 in Subjects With Cancer

This study has been completed.

Study NCT00075933. Last updated on March 19, 2008. Information provided by ArQule

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

ARQ 501 in Subjects With Cancer

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Cancer

Intervention ^†

Drug: ARQ 501

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2003

Completion Date

January 2007

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00075933

Organization ID

ARQ 501-101

Secondary IDs ^††

Study Sponsor ^†

ArQule

Collaborators ^††

Investigators ^†

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

March 2008

First Received Date ^†

January 12, 2004

Last Updated Date

March 19, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.