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Oral Calcitriol With Ketoconazole in CRPC

NCT03261336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-02-08

Study results available
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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

Conditions

  • Castration-resistant Prostate Cancer

Interventions

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

Sponsors & Collaborators

  • Donald Trump, MD

    lead OTHER

Principal Investigators

  • Skip (Donald) Trump, MD · CEO & Executive Director Inova Schar Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2018-02-28
Completion
2018-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261336 on ClinicalTrials.gov