Trial Outcomes & Findings for Oral Calcitriol With Ketoconazole in CRPC (NCT NCT03261336)

NCT ID: NCT03261336

Last Updated: 2021-02-08

Results Overview

Assessment of PSA every 4 weeks

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2021-02-08

Participant Flow

Study was closed at site in 2018 due to enrollment challenges. Only 1 patient was enrolled to trial. No evaluable results.

Participant milestones

Measure	Calcitriol, Ketoconazole, Hydrocortisone Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Calcitriol, Ketoconazole, Hydrocortisone Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Overall Study Adverse Event

1

Baseline Characteristics

Oral Calcitriol With Ketoconazole in CRPC

Baseline characteristics by cohort

Measure	Calcitriol, Ketoconazole, Hydrocortisone n=1 Participants Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	78 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 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
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Only one patient enrolled to study and was discontinued early due to AE.

Assessment of PSA every 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Only one patient was enrolled and was discontinued due to AE.

Objective tumor response among patients with measurable disease using modified RECIST1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Patient developed hypercalcemia and was discontinued from study. AE is known, not unexpected.

Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment

Outcome measures

Measure

Calcitriol, Ketoconazole, Hydrocortisone n=1 Participants Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Toxicity and Tolerability of Experimental Arm

1 Participants

Adverse Events

Calcitriol, Ketoconazole, Hydrocortisone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Calcitriol, Ketoconazole, Hydrocortisone n=1 participants at risk Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Blood and lymphatic system disorders hypercalcemia

100.0% 1/1 • Number of events 1 • AE data was collected on a single patient during one month in 2017. Definition consistent with clinicaltrials.gov

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Van Bebber, Sr. Director Clinical Trials

Inova Schar Cancer Institute

Phone: 5714720213

Email: Stephanie.VanBebber@inova.org

Results disclosure agreements

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