CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 127 enrolled / 127 target
Drug / intervention
ARN-509 (Phase 1) +1 moredrug
Likely dose
ARN-509 (Phase 1) 30 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01171898Phase 1CompletedMonitor (0.7/mo)Completion was 166mo ago
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An Open-Label, Phase 1/2, Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Patients With Progressive Advanced Castration-Resistant Prostate Cancer

Aragon Pharmaceuticals, Inc.·interventional·Posted Jul 29, 2010·Updated Jun 5, 2026

In Brief

A Phase 1 clinical trial evaluating ARN-509 (Phase 1) and ARN-509 (Phase 2) for Prostate Cancer. Completed, enrolled 127 participants across 15 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2010
Enrollment StartJul 26, 2010
Primary CompletionAug 20, 2012
Study CompletionJul 22, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.9 years ago

Arms & Interventions

Dose Escalation Cohort (Phase 1)experimental

ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily. Once Recommended Phase 2 Dose (RP2D) has been selected, Phase 1 participants being treated at the lower dose levels will be allowed to escalate to the RP2D level at the discretion of the primary investigator.

Drug: ARN-509 (Phase 1)
Non-metastatic CRPC (Phase 2)experimental

Participants with non-metastatic, treatment-naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) will be enrolled. ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.

Drug: ARN-509 (Phase 2)
Treatment-naive metastatic CRPC (Phase 2)experimental

Participants with treatment-naive metastatic CRPC will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.

Drug: ARN-509 (Phase 2)
Post-abiraterone metastatic CRPC (Phase 2)experimental

Participants with metastatic CRPC that are chemotherapy-naive, but have been previously treated with abiraterone will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.

Drug: ARN-509 (Phase 2)

Interventions

ARN-509 (Phase 1)drug

ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily.

ARN-509 (Phase 2)drug

ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.