Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00408902
First received: December 6, 2006
Last updated: January 26, 2015
Last verified: May 2014
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Drug: tandutinib
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
Patients were recruited from Cleveland Clinic between November 2006 and August 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TandutinibTreatment Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    TandutinibTreatment  
STARTED     10  
COMPLETED     0  
NOT COMPLETED     10  
Lack of Efficacy                 7  
Adverse Event                 3  



  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
TandutinibTreatment Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    TandutinibTreatment  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean ± Standard Deviation
  63.6  ± 8.3  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)   [ Time Frame: Up to 4 weeks after completion of study treatment ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Up to 4 weeks after completion of study treatment ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 4 weeks after completion of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Principal Investigator closed this study due to lack of response and toxicities of drug, therefore overall survival analysis was not done.


  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: Jorge Garcia MD
Organization: Case Comprehensive Cancer Center
phone: 216-444-7774
e-mail: garciaj4@ccf.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00408902     History of Changes
Other Study ID Numbers: NCI-2012-03014, CASE 10805, CDR0000518799, U01CA062502
Study First Received: December 6, 2006
Results First Received: January 26, 2015
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration