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

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. Identifier: NCT01450683
Recruitment Status : Terminated (Low accrual)
First Posted : October 12, 2011
Results First Posted : September 8, 2014
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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

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

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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      4 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      1  25.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1  25.0% 
White      2  50.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      1  25.0% 
Unknown or Not Reported      3  75.0% 

  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

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

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 )
First Submitted: September 30, 2011
First Posted: October 12, 2011
Results First Submitted: August 29, 2014
Results First Posted: September 8, 2014
Last Update Posted: April 11, 2017