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

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ClinicalTrials.gov Identifier: NCT01450683
Recruitment Status : Terminated (Low accrual)
First Posted : October 12, 2011
Results First Posted : September 8, 2014
Last Update Posted : April 11, 2017
Sponsor:
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
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole
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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

Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Itraconazole
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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

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Castrate-resistant Prostate Cancer Patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
78
(73 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
  25.0%
Unknown or Not Reported
3
  75.0%
1.Primary Outcome
Title Reduction in Serum PSA
Hide Description Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks
Time Frame 12 weeks treatment, with primary outcome assessed at 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Itraconazole
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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

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Itraconazole
Hide Arm/Group Description

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

All-Cause Mortality
Itraconazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Itraconazole
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1/4 (25.00%)  1
Ear and labyrinth disorders   
Other-Decreased Hearing  1/4 (25.00%)  1
Gastrointestinal disorders   
Diarrhea  2/4 (50.00%)  2
Nausea  4/4 (100.00%)  4
Constipation  2/4 (50.00%)  2
Edema Limbs  1/4 (25.00%)  1
General disorders   
Other-Sneezing  1/4 (25.00%)  1
Other-Shoulder Pain  1/4 (25.00%)  1
Fatigue  2/4 (50.00%)  2
Investigations   
Platelet Count Decreased  1/4 (25.00%)  1
Aspartate Aminotransferase Increased  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Anorexia  2/4 (50.00%)  2
Hyperglycemia  1/4 (25.00%)  1
Hypoalbuminemia  1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  1/4 (25.00%)  1
Neck Pain  1/4 (25.00%)  1
Nervous system disorders   
Memory Impairment  1/4 (25.00%)  1
Neuropathy  1/4 (25.00%)  1
Renal and urinary disorders   
Other-Nocturia  3/4 (75.00%)  3
Vascular disorders   
Facial Flushing  2/4 (50.00%)  2
1
Term from vocabulary, CTCAEv4
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
Layout table for Results Point of Contact information
Name/Title: Associate Professor of Medicine (Oncology)
Organization: Stanford University Medical Center
Phone: 650-725-2078
EMail: sandysri@stanford.edu
Layout table for additonal information
Responsible Party: Sandy Srinivas, Stanford University
ClinicalTrials.gov 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