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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on May 21, 2013