Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

Summary

This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases. The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).

Timeline

Start

2016-05

Primary completion

2018-06

Completion

2020-06

Publications

• Thellenberg-Karlsson C, Vjaters E, Kase M, Tammela T, Ojamaa K, Norming U, Nyman C, Andersson SO, Hublarovs O, Marquez-Holmberg M, Castellanos E, Ullen A, Holmberg A, Nilsson S. A randomised, double-blind, dose-finding, phase II multicentre study of ODX in the treatment of patients with castration-resistant prostate cancer and skeletal metastases. Eur J Cancer. 2023 Mar;181:198-207. doi: 10.1016/j.ejca.2022.12.006. Epub 2022 Dec 20.

Drugs

Indications