Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients

Summary

The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.

Timeline

Start

2011-03

Primary completion

2012-09

Completion

2012-09

Outcome

Outcome not reported

Stopped: “It was decided to discontinue the development in consideration of the results of a P1 study”

Publications

• Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.

Drugs

Indications