Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT01450683
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
  Hide 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
No text entered.

Reporting Groups
  Description
Itraconazole

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
    Itraconazole  
STARTED     4  
COMPLETED     2  
NOT COMPLETED     2  
Adverse Event                 2  



  Baseline Characteristics
  Hide 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
  Description
Itraconazole

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
    Itraconazole  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median ( Full Range )
  78  
  ( 73 to 88 )  
Gender  
[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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: sandysri@stanford.edu


No publications provided


Responsible Party: Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier: NCT01450683     History of Changes
Other Study ID Numbers: IRB-19413, SU-12032010-7271, PROS0037
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