Phase II Sunitinib Prog Met AIPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599313
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):
US Oncology Research

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Prostate Cancer
Intervention: Drug: Sunitinib

  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
Sunitinib Malate Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)

Participant Flow:   Overall Study
    Sunitinib Malate
Adverse Event                19 
Disease Progression                12 
Patient Request                4 
Ineligible                1 

  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.
Total participants

Reporting Groups
Sunitinib Malate Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)

Baseline Measures
   Sunitinib Malate 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 70.0  (9.34) 
[Units: Participants]
Female   0 
Male   36 
Race/Ethnicity, Customized 
[Units: Participants]
Caucasian   32 
Black   3 
Hispanic   1 
Region of Enrollment 
[Units: Participants]
United States   36 

  Outcome Measures

1.  Primary:   Median Progression-free Survival (PFS) Time at 1-year.   [ Time Frame: 12 months ]

2.  Secondary:   Overal Survival (OS) Rate at 1-year.   [ Time Frame: 12 months ]

3.  Secondary:   Prostate Specific Antigen (PSA) Response   [ Time Frame: 12 months ]

4.  Secondary:   Change of PSA Doubling Time   [ Time Frame: Baselie and up to 12 months ]

5.  Secondary:   Objective Response Rate (ORR) st   [ Time Frame: 12 months ]

6.  Secondary:   Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.   [ Time Frame: 12 months ]

  Serious Adverse Events

  Other Adverse Events

  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Dr. Guru Sonpavde
Organization: Texas Oncology Cancer Center
phone: 2813327505

Responsible Party: US Oncology Research Identifier: NCT00599313     History of Changes
Other Study ID Numbers: 05112
2006-0012 ( Other Identifier: Pfizer )
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: January 20, 2016
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016