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A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00090545
First received: August 27, 2004
Last updated: August 28, 2012
Last verified: August 2012
Results First Received: July 23, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: BAY 43-9006

  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
No text entered.

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
First Stage - Disease Progression

The first stage was to rule out the probability of 4 month progression free survival.

400 mg BAY 43-9006 orally twice daily in 28 day cycles.

Second Stage - Increased Accrual

Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.

400 mg BAY 43-9006 orally twice daily in 28 day cycles.


Participant Flow:   Overall Study
    First Stage - Disease Progression     Second Stage - Increased Accrual  
STARTED     22     24  
COMPLETED     0     0  
NOT COMPLETED     22     24  
Disease progression on study                 21                 17  
Refused further treatment                 1                 4  
Death                 0                 1  
Adverse Event                 0                 2  



  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
First Stage - Disease Progression

The first stage was to rule out the probability of 4 month progression free survival.

Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.

Second Stage - Increased Accrual

Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.

Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles

Total Total of all reporting groups

Baseline Measures
    First Stage - Disease Progression     Second Stage - Increased Accrual     Total  
Number of Participants  
[units: participants]
  22     24     46  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     10     23  
>=65 years     9     14     23  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 7.04     68.08  ± 10.17     66.52  ± 8.87  
Gender  
[units: participants]
     
Female     0     0     0  
Male     22     24     46  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     21     23     44  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     5     6  
White     21     19     40  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     22     24     46  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 4 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 49 months ]


  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 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: William Dahut, M.D.
Organization: National Cancer Institute, National Institues of Health
phone: 301-435-8183
e-mail: dahutw@mail.nih.gov


Publications of Results:
Other Publications:


Responsible Party: William L. Dahut, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00090545     History of Changes
Obsolete Identifiers: NCT00093431
Other Study ID Numbers: 040262, 04-C-0262
Study First Received: August 27, 2004
Results First Received: July 23, 2012
Last Updated: August 28, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration