Trial Outcomes & Findings for Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy (NCT NCT00895310)

NCT ID: NCT00895310

Last Updated: 2017-03-30

Results Overview

Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a \>=50% decrease in PSA.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years
• Results posted on: 2017-03-30

Participant Flow

Recruitment took place at a single institution.

Participant milestones

Measure	Ketoconazole Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening) Ketoconazole: Ketoconazole is taken three times a day by mouth.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ketoconazole Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening) Ketoconazole: Ketoconazole is taken three times a day by mouth.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy

Baseline characteristics by cohort

Measure	Ketoconazole n=30 Participants Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
Age, Continuous	72 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years

Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.

Outcome measures

Measure	Ketoconazole n=29 Participants Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)	14 Participants

SECONDARY outcome

Timeframe: From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years

Outcome measures

Measure	Ketoconazole n=29 Participants Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
PSA Response (>30% From Baseline)	17 Participants

SECONDARY outcome

Timeframe: From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years

Response Evaluation Criteria In Solid Tumors (RECIST) radiographic criteria for progression

Outcome measures

Measure	Ketoconazole n=29 Participants Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
Progression Free Survival	138 Days Interval 80.0 to 260.0

SECONDARY outcome

Timeframe: From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years

Outcome measures

Measure	Ketoconazole n=29 Participants Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
Duration of Stable Disease	123 Days Interval 2.0 to 728.0

Adverse Events

Ketoconazole

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketoconazole n=30 participants at risk Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm Ketoconazole: Ketoconazole is taken three times a day by mouth.
Cardiac disorders Angina	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Cardiac disorders Congestive Heart Failure	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Cardiac disorders Myocarditis	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Cardiac disorders Atrial Fibrillation	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
General disorders Weight Gain	6.7% 2/30 • Number of events 2 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
General disorders Fatigue	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Metabolism and nutrition disorders Transaminitis	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
General disorders Hypoantremia	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Metabolism and nutrition disorders Hyperglycemia	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Musculoskeletal and connective tissue disorders Fracture	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Nervous system disorders Syncope	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Psychiatric disorders Mood Alteration	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Psychiatric disorders Psychosis	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
General disorders Pain	6.7% 2/30 • Number of events 2 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Cardiac disorders Myocardial Infarction	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • Number of events 1 • From the start of treatment until 8-12 weeks after removal from study, assessed for up to 2 years.

Additional Information

Analyst

University of California Davis

Phone: 9167340294

Email: pkaujla@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place