ARQ 501 in Subjects With Cancer

April 27, 2009 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 12, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQ 501-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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