Trial Outcomes & Findings for A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy (NCT NCT00887458)

Results Overview

To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline \[or nadir (lowest)\] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2017-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Low Dose Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Overall Study STARTED	17	29
Overall Study COMPLETED	17	25
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose n=17 Participants Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose n=29 Participants Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)	Total n=46 Participants Total of all reporting groups
Age, Continuous	73 years n=93 Participants	71 years n=4 Participants	73 years n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	9 Participants n=4 Participants	10 Participants n=27 Participants
Age, Categorical >=65 years	16 Participants n=93 Participants	20 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	29 Participants n=4 Participants	46 Participants n=27 Participants
Region of Enrollment United States	17 participants n=93 Participants	29 participants n=4 Participants	46 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Based on how many participants were evaluable for the study primary endpoint

To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline \[or nadir (lowest)\] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.

Outcome measures

Outcome measures
Measure	Low Dose Itraconazole n=17 Participants Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose Itraconazole n=25 Participants Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.	11.8 percent of patients Interval 1.5 to 36.4	48 percent of patients Interval 27.8 to 68.7

SECONDARY outcome

Timeframe: Baseline and approximately 2 years from open enrollment

Population: One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.

Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.

Outcome measures

Outcome measures
Measure	Low Dose Itraconazole n=17 Participants Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose Itraconazole n=28 Participants Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.	0 percentage Interval 0.0 to 19.5	14.3 percentage Interval 4.0 to 32.7

Adverse Events

Low Dose

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

High Dose

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose n=17 participants at risk Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose n=29 participants at risk Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
General disorders fatigue	5.9% 1/17 • Number of events 1 • 4 years	0.00% 0/29 • 4 years

Other adverse events

Other adverse events
Measure	Low Dose n=17 participants at risk Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)	High Dose n=29 participants at risk Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
General disorders fatigue	52.9% 9/17 • Number of events 9 • 4 years	20.7% 6/29 • Number of events 6 • 4 years
Gastrointestinal disorders anorexia	11.8% 2/17 • Number of events 2 • 4 years	17.2% 5/29 • Number of events 5 • 4 years
Skin and subcutaneous tissue disorders rash	17.6% 3/17 • Number of events 3 • 4 years	6.9% 2/29 • Number of events 2 • 4 years
Cardiac disorders hypertension	0.00% 0/17 • 4 years	31.0% 9/29 • Number of events 9 • 4 years
Metabolism and nutrition disorders hypokalemia	0.00% 0/17 • 4 years	17.2% 5/29 • Number of events 5 • 4 years

Additional Information

Dr. Michael Carducci

Johns Hopkins University

Phone: 410-614-3977

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place