Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT01663415CI-TRIAL-00008036withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A business decision was made to not initiate this study.
Summary
Brief summary (as posted)
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzalutamide
- interventionNames
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Radiographic progression free survival (PFS)
- timeFrame
- 26 months
- description
- Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
Secondary outcomes (6)
- measure
- Overall survival
- timeFrame
- 26 months
- description
- Time from first dose on Day 1 to death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Progressive prostate cancer while on androgen deprivation therapy * Castrate testosterone level * Maintenance of surgical or medical castration for duration of study * Radiographically visible metastatic disease * Symptomatic from prostate cancer * Eastern Cooperative Oncology Group (ECOG) 0-2 * Life expectancy \>=6 months Exclusion Criteria: * Brain metastases or leptomeningeal disease * Prior cytotoxic chemotherapy for prostate cancer * Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor * History of seizure or condition that may predispose to seizure * History of loss of consciousness or transient ischemic attack within 12 months * Clinically significant cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.