A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Michael A. Carducci, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00887458
First received: April 23, 2009
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: December 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Itraconazole 200 mg
Drug: Itraconazole 300mg

  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
No text entered.

Reporting Groups
  Description
Low Dose

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

High Dose

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)


Participant Flow:   Overall Study
    Low Dose     High Dose  
STARTED     17     29  
COMPLETED     17     25  
NOT COMPLETED     0     4  



  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
Low Dose

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

High Dose

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Total Total of all reporting groups

Baseline Measures
    Low Dose     High Dose     Total  
Number of Participants  
[units: participants]
  17     29     46  
Age  
[units: years]
Median ( Full Range )
  73  
  ( 60 to 81 )  
  71  
  ( 52 to 89 )  
  73  
  ( 52 to 89 )  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     9     10  
>=65 years     16     20     36  
Gender  
[units: participants]
     
Female     0     0     0  
Male     17     29     46  
Region of Enrollment  
[units: participants]
     
United States     17     29     46  



  Outcome Measures

1.  Primary:   To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.   [ Time Frame: Up to 24 weeks ]

2.  Secondary:   To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.   [ Time Frame: approximately 2 years from open enrollment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Dr. Michael Carducci
Organization: Johns Hopkins University
phone: 410-614-3977
e-mail: carducci@jhmi.edu


No publications provided


Responsible Party: Michael A. Carducci, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00887458     History of Changes
Other Study ID Numbers: J0932, JHMI-IRB number: NA_00027099
Study First Received: April 23, 2009
Results First Received: December 11, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board