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Oral Calcitriol With Ketoconazole in CRPC

Castration-resistant Prostate Cancer Clinical Trial

Official title:
A Phase II Study of Oral Calcitriol in Combination With Ketoconazole in Castration Resistant Prostate Cancer, Progressing Despite Primary ADT and Abiraterone

Clinical Trial Summary

The aim of this study is to estimate the PSA response rate with the use of ketoconazole (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has progressed despite abiraterone

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03261336
Study type Interventional
Source Inova Health Care Services
Contact
Status Terminated
Phase Phase 2
Start date January 6, 2017
Completion date February 28, 2018
View Details
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