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
Results First Posted : February 8, 2021
Last Update Posted : February 8, 2021
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Castration-resistant Prostate Cancer |
Intervention |
Drug: Calcitriol, Ketoconazole, Hydrocortisone |
Enrollment | 1 |
Recruitment Details | Study was closed at site in 2018 due to enrollment challenges. Only 1 patient was enrolled to trial. No evaluable results. |
Pre-assignment Details |
Arm/Group Title | Calcitriol, Ketoconazole, Hydrocortisone |
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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 |
Period Title: Overall Study | |
Started | 1 |
Completed | 0 |
Not Completed | 1 |
Reason Not Completed | |
Adverse Event | 1 |
Arm/Group Title | Calcitriol, Ketoconazole, Hydrocortisone | |
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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 |
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Overall Number of Baseline Participants | 1 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
1 100.0%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 1 participants | |
78
(78 to 78)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
Female |
0 0.0%
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Male |
1 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
1 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 1 participants |
1 |
Name/Title: | Stephanie Van Bebber, Sr. Director Clinical Trials |
Organization: | Inova Schar Cancer Institute |
Phone: | 5714720213 |
EMail: | Stephanie.VanBebber@inova.org |
Responsible Party: | Donald Trump, MD, Inova Health Care Services |
ClinicalTrials.gov Identifier: | NCT03261336 |
Other Study ID Numbers: |
16-2200 |
First Submitted: | July 12, 2017 |
First Posted: | August 25, 2017 |
Results First Submitted: | January 19, 2021 |
Results First Posted: | February 8, 2021 |
Last Update Posted: | February 8, 2021 |