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An Extension Study for Patients Previously Treated With ARQ 501

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622063
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
ArQule

Tracking Information
First Submitted Date  ICMJE February 12, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date February 28, 2013
Study Start Date  ICMJE December 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501 [ Time Frame: No time frame ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
To collect additional safety and tolerability information for ARQ 501 treatment [ Time Frame: No time frame ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study for Patients Previously Treated With ARQ 501
Official Title  ICMJE An Extension Study for Patients Previously Treated With ARQ 501
Brief Summary To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: ARQ 501
Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
1
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00622063
Other Study ID Numbers  ICMJE ARQ 501-115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ArQule
Study Sponsor  ICMJE ArQule
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neil Nathan Senzer, MD Mary Crowley Medical Research Center
PRS Account ArQule
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP