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Oral Calcitriol With Ketoconazole in CRPC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Oral Calcitriol With Ketoconazole in CRPC

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

NCT03261336•Donald Trump, MD

View on ClinicalTrials.gov

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

Detailed 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For inclusion in the trial, a patient must fulfill all of the following criteria:
•1. Greater than or equal to 18 years of age. The effects of ketoconazole and high-dose calcitriol have not been studied adequately in patients \<18 years of age and prostate cancer has not been described in children.
•2. Histologically or cytologically confirmed adenocarcinoma consistent clinically with androgen Independent prostate cancer
•3. Measurable disease with elevated PSA or evaluable disease (PSA elevation will constitute evaluable disease).
•4. No cytotoxic chemotherapy for extensive disease prior to study entry will be allowed; given the recent data regarding the role of docetaxel + ADT in patients beginning ADT for advanced disease, such "adjuvant chemotherapy will be allowed (no more than 6 cycles) retinoids, vitamin D analogues, PPAR agonists or antagonists, antiandrogens, progestational agents, estrogens, PC-SPES, LHRH analogues, vaccines, cytokines will not be considered "cytotoxics." Patients who have previously received ketoconazole + glucocorticoids will NOT be eligible for this trial.
•5. Patients who have received antiandrogens or progestational agents as therapy for prostate cancer must discontinue therapy and demonstrate a rising PSA \> 28 days following discontinuation (antiandrogen withdrawal - AAW) (\>42 days for bicalutamide or nilutamide). Patients who receive megestrol acetate as therapy for "hot flashes" at a dose of \<40mg per day may continue this therapy during this trial. The dose of the megestrol acetate should not be changed during protocol treatment. Patients undergoing androgen deprivation using LHRH analogues must continue such agents or undergo orchiectomy to maintain castrate levels of testosterone.
•6. Patients must have prostate cancer that is advanced or recurrent.
•7. Patients should not have received any chemotherapy or investigational agents for at least 28 days before entering the study.
•8. Eastern Clinical Oncology Group performance status 0 or 1
•9. Life expectancy \>3 months.
+8 more criteria

Exclusion Criteria

•Any of the following is a criterion for exclusion from the trial:
•1. Known severe hypersensitivity to ketoconazole, calcitriol or any of the excipients of these products.
•2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to calcitriol, ketoconazole, or other agents used in study.
•3. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
•4. History of kidney, ureteral, or bladder stones within the last 5 years
•5. Heart failure or significant heart disease including significant arrhythmias, myocardial infarction within the last 3 months, unstable angina, documented ejection fraction \<30%, or current digoxin therapy.
•6. Thiazide therapy within 7 days from entering the study.
•7. Requirement for concurrent systemic glucocorticoid therapy at greater than physiologic replacement doses
•8. Unwillingness to stop calcium supplementation.
•9. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
+12 more criteria

Locations (1)

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Key Dates

Start Date

January 6, 2017

Primary Completion Date

February 28, 2018

Completion Date

February 28, 2018

Last Updated

February 8, 2021

Enrollment

ACTUAL participants

Conditions

Castration-resistant Prostate Cancer

Interventions

Calcitriol, Ketoconazole, Hydrocortisone

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Oral Calcitriol With Ketoconazole in CRPC

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer