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Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00861913
First received: March 13, 2009
Last updated: June 9, 2014
Last verified: June 2014
Results First Received: November 7, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage IV Melanoma
Interventions: Drug: pazopanib hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From April 2009 to July 2009, 13 participants were registered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants were evaluable for all endpoints and toxicity.

Reporting Groups
  Description
Treatment (Pazopanib Hydrochloride) Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Pazopanib Hydrochloride)  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Pazopanib Hydrochloride) Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Pazopanib Hydrochloride)  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Median ( Full Range )
  64  
  ( 24 to 86 )  
Gender  
[units: participants]
 
Female     3  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures
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1.  Primary:   Tumor Response Rate   [ Time Frame: Up to 5 years ]

2.  Primary:   Toxicity   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: From registration to death due to any cause, assessed up to 5 years ]

4.  Secondary:   Progression Free Survival   [ Time Frame: From registration to documentation of disease progression, assessed up to 5 years ]

5.  Secondary:   Duration of Response   [ Time Frame: From time of documented response to the date progression is documented, assessed up to 5 years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amy M. Weise, D. O.
Organization: Karmanos Cancer Institute, Wayne State University
phone: 313-576-8952


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00861913     History of Changes
Other Study ID Numbers: NCI-2009-01163, NCI-2009-01163, CDR0000637188, MAYO-MC0875, MC0875, 8218, N01CM62205, P30CA015083
Study First Received: March 13, 2009
Results First Received: November 7, 2013
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration