Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

This study has been completed.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00694096
First received: June 6, 2008
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: October 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Renal Cell Cancer
Intervention: Drug: Sunitinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Arm 1 - Sunitinib 37.5 mg Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.

Participant Flow:   Overall Study
    Arm 1 - Sunitinib 37.5 mg  
STARTED     25  
COMPLETED     20  
NOT COMPLETED     5  
Withdrawal by Subject                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Arm 1 - Sunitinib 37.5 mg Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.

Baseline Measures
    Arm 1 - Sunitinib 37.5 mg  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Median (Full Range)
  67  
  (50 to 86)  
Gender  
[units: participants]
 
Female     10  
Male     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Metabolic Response   [ Time Frame: 4 weeks ]

2.  Primary:   Proliferative Response   [ Time Frame: 4 weeks ]

3.  Secondary:   Overall Survival   [ Time Frame: 2399 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Mark Wade, Ph.D. - Compliance Officer
Organization: Huntsman Cancer Institute
phone: 801-213-5746
e-mail: mark.wade@hci.utah.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00694096     History of Changes
Other Study ID Numbers: HCI21897
Study First Received: June 6, 2008
Results First Received: October 28, 2015
Last Updated: October 28, 2015
Health Authority: United States: Food and Drug Administration