A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
NCT ID: NCT02361086
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2014-06-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen 1: 7dayPM+DT
VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week with a 2-week dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Regimen 2: 7dayPM-DT
VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Regimen 3: 7dayAM+DT
VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Regimen 4: 7dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Regimen 5: 5dayPM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Regimen 6: 5dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Interventions
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VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a minimum serum PSA level of \>2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
* Patients must have castrate levels of testosterone (\<50 ng/dl \[1.74 nmol/l\]).
* Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
* Patients must have an ECOG Performance Score of 0 or 1.
Exclusion Criteria
* Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
* Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
* Patients who have received TOK-001 (Galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
* Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for \> 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for \< 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
* Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
* Patients who have received palliative radiotherapy within 4 weeks of study entry.
* Patients with a history within the last 3 years of another invasive malignancy.
18 Years
MALE
No
Sponsors
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Innocrin Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Eisner
Role: STUDY_DIRECTOR
Innocrin Pharmaceutical
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Urology Cancer Center
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Countries
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Other Identifiers
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INO-VT-464-CL-004
Identifier Type: -
Identifier Source: org_study_id
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