An Extension Study for Patients Previously Treated With ARQ 501

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT00622063
First received: February 12, 2008
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501


Condition Intervention Phase
Cancer
Drug: ARQ 501
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study for Patients Previously Treated With ARQ 501

Further study details as provided by ArQule:

Primary Outcome Measures:
  • To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501 [ Time Frame: No time frame ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To collect additional safety and tolerability information for ARQ 501 treatment [ Time Frame: No time frame ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: December 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARQ 501
    Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment

Exclusion Criteria:

  • Have not received previous treatment with ARQ 501 under a treatment protocol
  • Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
  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: NCT00622063

Locations
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
ArQule
Investigators
Principal Investigator: Neil Nathan Senzer, MD Mary Crowley Medical Research Center
  More Information

No publications provided

Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT00622063     History of Changes
Other Study ID Numbers: ARQ 501-115
Study First Received: February 12, 2008
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
cancer, solid tumor

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 21, 2014