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Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00495625
First received: June 29, 2007
Last updated: March 22, 2012
Last verified: December 2011
History of Changes
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Cancer
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
All patients with unresectable or metastatic hepatocellular cancer (HCC) seen at the Moffitt Cancer Center Gastrointestinal (GI) Clinic were screened for eligibility to be enrolled in the study.

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
Sunitinib Malate (SUO11248) Treatment Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Participant Flow:   Overall Study
    Sunitinib Malate (SUO11248) Treatment  
STARTED     33  
COMPLETED     23  
NOT COMPLETED     10  
Did not complete at least 1 42 day cycle                 10  



  Baseline Characteristics
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Reporting Groups
  Description
Sunitinib Malate (SUO11248) Treatment Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Baseline Measures
    Sunitinib Malate (SUO11248) Treatment  
Number of Participants  
[units: participants]
 		  33  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     12  
Age  
[units: years]
Mean ( Full Range ) 		  60.65  
  ( 24 to 88 )  
Gender  
[units: participants]
 		 
Female     7  
Male     26  
Region of Enrollment  
[units: participants]
 		 
United States     33  



  Outcome Measures
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1.  Primary:   Number of Participants With Partial Response (PR) at Interim Analysis   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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2.  Primary:   Number of Participants With Stable Disease (SD) at Interim Analysis   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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3.  Primary:   Number of Participants With Progressive Disease (PD) at Interim Analysis   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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4.  Secondary:   Participant Time to Tumor Progression (TTP)   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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5.  Secondary:   Number of Participants With Overall Survival (OS)   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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6.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: On Treatment to Off Study - average of 7 months per participant ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.  


Results Point of Contact:  
Name/Title: Jonathan Strosberg, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-7257
e-mail: jonathan.strosberg@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00495625     History of Changes
Other Study ID Numbers: MCC-14733, Pfizer #2005-0880
Study First Received: June 29, 2007
Results First Received: January 12, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board