Trial Outcomes & Findings for Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy (NCT NCT01450683)
NCT ID: NCT01450683
Last Updated: 2017-04-11
Results Overview
Number of subjects with \> 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
12 weeks treatment, with primary outcome assessed at 15 weeks
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy
Baseline characteristics by cohort
| Measure |
Itraconazole
n=4 Participants
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
|
|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks treatment, with primary outcome assessed at 15 weeksNumber of subjects with \> 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks
Outcome measures
| Measure |
Itraconazole
n=4 Participants
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
|
|---|---|
|
Reduction in Serum PSA
|
0 participants
|
Adverse Events
Itraconazole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Itraconazole
n=4 participants at risk
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
|
|---|---|
|
Renal and urinary disorders
Other-Nocturia
|
75.0%
3/4 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Other-Sneezing
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 4
|
|
Ear and labyrinth disorders
Other-Decreased Hearing
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Memory Impairment
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Facial Flushing
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Other-Shoulder Pain
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Neuropathy
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Edema Limbs
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Platelet Count Decreased
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
1/4 • Number of events 1
|
Additional Information
Associate Professor of Medicine (Oncology)
Stanford University Medical Center
Phone: 650-725-2078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place