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Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy

This study has been terminated.
(Low accrual)
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University Identifier:
First received: September 30, 2011
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: August 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate Cancer
Prostatic Neoplasms
Castrate-resistant Prostate Cancer (CRPC)
Androgen-insensitive Prostate Cancer
Hormone-refractory Prostate Cancer
Metastatic Disease
Intervention: Drug: Itraconazole

  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

Itraconazole: 600 mg/day oral (PO)

IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Participant Flow:   Overall Study
Adverse Event                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.
Castrate-resistant Prostate Cancer Patients

Reporting Groups

Itraconazole: 600 mg/day oral (PO)

IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (73 to 88) 
[Units: Participants]
Female   0 
Male   4 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   2 
More than one race   0 
Unknown or Not Reported   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   0 
Not Hispanic or Latino   1 
Unknown or Not Reported   3 

  Outcome Measures

1.  Primary:   Reduction in Serum PSA   [ Time Frame: 12 weeks treatment, with primary outcome assessed at 15 weeks ]

  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: Associate Professor of Medicine (Oncology)
Organization: Stanford University Medical Center
phone: 650-725-2078

Responsible Party: Sandy Srinivas, Stanford University Identifier: NCT01450683     History of Changes
Other Study ID Numbers: IRB-19413
SU-12032010-7271 ( Other Identifier: Stanford University )
PROS0037 ( Other Identifier: OnCore )
Study First Received: September 30, 2011
Results First Received: August 29, 2014
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration