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NCT01171898 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
A Phase 1 study, sponsored by Aragon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
NCT01171898: Completed Phase 1 study, sponsored by Aragon Pharmaceuticals.
NCT01171898 is a Phase 1 study that has completed, run by Aragon Pharmaceuticals. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01171898, a Phase 1 study, has completed, sponsored by Aragon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.
Primary Outcome
Percentage of participants with \>=50% decrease in PSA compared to baseline were assessed at Week 12. PSA progression was defined by the protocol-specific Prostate Cancer Working Group 2 (PCWG2) criteria: PSA increase greater than or equal to \[\>=\] 25 percent \[%\] and \>=2 nanogram per milliliter \[ng/mL\] above the nadir confirmed \>=3 weeks later; or \>=25% and \>=2 ng/mL above baseline PSA after 12 weeks.
Interventions
- DRUG ARN-509 (Phase 1)
- DRUG ARN-509 (Phase 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2010-07-26 |
| Est. Completion | 2025-07-22 |
| Phase | Phase 1 |
What the finished NCT01171898 record still lists
NCT01171898 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 0 conditions, and to 2 interventions - of which ARN-509 (Phase 1) is the first listed.
NCT01171898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01171898 about?
NCT01171898 is a clinical study titled "Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)". The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of pat...
What is the current status of trial NCT01171898?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2010-07-26. Estimated completion is 2025-07-22.
What interventions are being tested in trial NCT01171898?
The interventions under investigation include: ARN-509 (Phase 1) (DRUG), ARN-509 (Phase 2) (DRUG).
Who is sponsoring clinical trial NCT01171898?
This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01171898's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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