Clinical trial · Interventional
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients With Castration-Resistant Prostate Cancer
NCT02361086CI-TRIAL-00036889completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| CRPC | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VT-464: given orally once daily in 28 day cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Regimen 1: 7dayPM+DT
- description
- 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.
- interventionNames
- Drug: VT-464: given orally once daily in 28 day cycles
- type
- EXPERIMENTAL
- label
- Regimen 2: 7dayPM-DT
- description
- VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
- interventionNames
- Drug: VT-464: given orally once daily in 28 day cycles
- type
- EXPERIMENTAL
- label
- Regimen 3: 7dayAM+DT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate. * 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. Key Exclusion Criteria: * Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.