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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:
ClinicalTrials.gov Identifier:
NCT00887458
First Posted: April 24, 2009
Last Update Posted: October 16, 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:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: December 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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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
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.
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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 
Overall Participants Analyzed 
[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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1   5.9%      9  31.0%      10  21.7% 
>=65 years      16  94.1%      20  69.0%      36  78.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      17 100.0%      29 100.0%      46 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   29   46 


  Outcome Measures
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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: Baseline and approximately 2 years from open enrollment ]


  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



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00887458     History of Changes
Other Study ID Numbers: J0932
JHMI-IRB number: NA_00027099
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: December 11, 2013
Results First Posted: January 27, 2014
Last Update Posted: October 16, 2017