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A Study of Imatinib and Docetaxel in Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00251225
First Posted: November 9, 2005
Last Update Posted: August 9, 2017
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh
Results First Submitted: January 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Gleevec
Drug: Docetaxel

  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
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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
Hormone Refractory Prostate Cancer Patients Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days

Participant Flow:   Overall Study
    Hormone Refractory Prostate Cancer Patients
STARTED   49 
COMPLETED   49 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Hormone Refractory Prostate Cancer Patients Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days

Baseline Measures
   Hormone Refractory Prostate Cancer Patients 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Years]
Median (Full Range)
 69 
 (54 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      49 100.0% 


  Outcome Measures
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1.  Primary:   Overall Time To Progression (TTP)   [ Time Frame: Up to 24 months ]

2.  Secondary:   Prostate-Specific Antigen (PSA) Response Rate   [ Time Frame: Up to 12 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 60 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leonard J. Appleman, MD, PhD
Organization: University of Pittsburgh Cancer Institute
phone: 412-648-6507
e-mail: applemanlj@upmc.edu



Responsible Party: Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00251225     History of Changes
Other Study ID Numbers: 05-019
First Submitted: November 8, 2005
First Posted: November 9, 2005
Results First Submitted: January 15, 2016
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017