Clinical Trials Search
Clinical Trial 18492
Cancer Type: Genitourinary
Interventions:Seviteronel; VT-464 (Seviteronel)
Study Type: Treatment
Phase of Study: Phase II
- Jingsong Zhang
A Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of VT-464 in Patients with Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone
The purpose of this study is to determine how well the cancer is responding to study treatment with VT-464. The study will also examine the safety of VT-464. Finally, investigators will be studying different properties of the cancer before study treatment to look for clues which may help us know which patients are most likely to respond to this drug in the future.
5.1 Primary Objective: To determine the proportion of patients who have >=50% PSA decline at or within 12 weeks of starting treatment with VT-464. 5.2 Secondary Objectives: To measure the proportion of patients who have >=50% PSA decline at 12 weeks from start of treatment with VT-464. To determine median rPFS and 6-month rPFS rate. To determine radiologic response rate. To determine overall survival (OS). To determine safety and tolerability. 5.3 Exploratory Objective: To associate predictive biomarkers (Table 1) with clinical outcomes to VT-464 in CRPC patients who have progressed while on enzalutamide or abiraterone.