ARQ 501 in Subjects With Cancer

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00075933
First received: January 12, 2004
Last updated: April 27, 2009
Last verified: April 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Beta-lapachone
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Radiation-Sensitizing Agents
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014