NCT03300505

ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer

ARRO-CITO: (UMCC 2017.055) Phase Ib/II Single-Arm Multi-Center Study of IONIS-AR-2.5Rx, a Next Generation Androgen Receptor Antisense Oligonucleotide, in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of ARRx (also known as AZD5312) plus enzalutamide in patients with metastatic castration resistant prostate cancer.

Detailed description

This is a single dose-finding one-arm phase Ib/II trial to determine the maximum tolerated dose (MTD) from among three dose levels of ARRx in combination with a fixed dose of enzalutamide and to obtain a preliminary estimate of efficacy at this MTD, as measured by PSA response rate. Success for the trial is defined as finding a dose level that is likely to be both tolerable and effective. The study was originally registered as a phase 1/ phase 2 study; however, the study was cancelled by the sponsor before opening the phase 2 portion. Outcome measures were updated to include those relevant to the Phase 1 portion as the study was terminated before enrolling into phase 2

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ARRx	Given intravenously (IV)
DRUG	Enzalutamide	Given by mouth (PO)

Timeline

• Start date: 2019-05-31
• Primary completion: 2023-01-24
• Completion: 2023-01-24
• First posted: 2017-10-03
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study