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Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate

NCT01792687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-03-04

No results posted yet for this study

Summary

This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer.

Conditions

Interventions

DRUG

ARN-509

Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, daily

DRUG

Abiraterone acetate

1,000 mg, oral, daily

DRUG

Prednisone

5 mg, oral, daily

Sponsors & Collaborators

  • Aragon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Aragon Pharmaceuticals, Inc Clinical Trial · Aragon Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-05
Primary Completion
2014-05-10
Completion
2024-02-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792687 on ClinicalTrials.gov