Oral Calcitriol With Ketoconazole in CRPC
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|ClinicalTrials.gov Identifier: NCT03261336|
Recruitment Status : Terminated (can not meet enrollment)
First Posted : August 25, 2017
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Castration-resistant Prostate Cancer||Drug: Calcitriol, Ketoconazole, Hydrocortisone||Phase 2|
This study will aim to describe objective tumor responses to the combination of oral calcitriol and ketoconazole and hydrocortisone-among patients with measurable disease using modified RECIST 1.1 criteria.
Additionally, we will determine toxicities, and tolerability of oral calcitriol combination with daily oral ketoconazole, and hydrocortisone in this patient population.
this is a single arm phase II trial of ketoconazole (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has progressed despite abiraterone
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Calcitriol 10mcg QD X3, weekly + Ketoconazole 400mg po TID and Hydrocortisone 20mg AM, 10mg PM|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Calcitriol in Combination With Ketoconazole in Castration Resistant Prostate Cancer, Progressing Despite Primary ADT and Abiraterone|
|Actual Study Start Date :||January 6, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
Experimental: Calcitriol, Ketoconazole, Hydrocortisone
Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).
Drug: 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
- PSA response rate [ Time Frame: 2 years ]Assessment of PSA every 4 weeks
- Tumor response [ Time Frame: 2 years ]Objective tumor response among patients with measurable disease using modified RECIST1.1
- Toxicity and tolerability of experimental arm [ Time Frame: 2 years ]Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261336
|United States, Virginia|
|Inova Schar Cancer Institute|
|Fairfax, Virginia, United States, 22031|
|Principal Investigator:||Skip (Donald) Trump, MD||CEO & Executive Director Inova Schar Cancer Institute|