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: December 6, 2013
Last verified: December 2013
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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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
Study First Received: March 13, 2009
Results First Received: November 7, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration