Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00716625
First received: July 15, 2008
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: August 29, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Carcinoma, Renal Cell
Intervention: Drug: sunitinib malate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sunitinib Malate Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.

Participant Flow:   Overall Study
    Sunitinib Malate
STARTED   1674 
COMPLETED   1673 
NOT COMPLETED   1 
Safety was not Assessable                1 



  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.
In total, 1674 participants were enrolled in the study. Of the 1674 participants, 1 participant was excluded from the baseline analysis because the safety was not assessable.

Reporting Groups
  Description
Sunitinib Malate Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.

Baseline Measures
   Sunitinib Malate 
Overall Participants Analyzed 
[Units: Participants]
 1673 
Age, Customized 
[Units: Participants]
 
<15 years   1 
>=15 and <65 years   940 
˃=65 years   712 
Unknown   20 
Gender 
[Units: Participants]
Count of Participants
 
Female      421  25.2% 
Male      1252  74.8% 


  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Related Adverse Events   [ Time Frame: MAX 2 Years ]

2.  Primary:   Objective Response Rate   [ Time Frame: MAX 2 Years ]

3.  Secondary:   Number of Participants With Treatment-Related Adverse Events in Pediatric Population   [ Time Frame: MAX 2 Years ]

4.  Secondary:   Number of Participants With Treatment-Related Adverse Events in Elderly Population   [ Time Frame: MAX 2 Years ]

5.  Secondary:   Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment   [ Time Frame: MAX 2 Years ]

6.  Secondary:   Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment   [ Time Frame: MAX 2 Years ]

7.  Secondary:   Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors   [ Time Frame: MAX 2 Years ]

8.  Secondary:   Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment   [ Time Frame: MAX 2 Years ]

9.  Secondary:   Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation   [ Time Frame: MAX 2 Years ]

10.  Other Pre-specified:   Number of Participants With Treatment-Related Serious Adverse Events   [ Time Frame: MAX 2 Years ]

11.  Other Pre-specified:   Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert   [ Time Frame: MAX 2 Years ]

12.  Other Pre-specified:   Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)   [ Time Frame: MAX 2 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00716625     History of Changes
Other Study ID Numbers: A6181176
Study First Received: July 15, 2008
Results First Received: August 29, 2016
Last Updated: November 17, 2016