drugset / Trial / NCT02162836
A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate cancer that is resistant to medical \[for example. hormonal\] or surgical treatments).
Timeline
- Start
- 2014-06-27
- Primary completion
- 2019-05-27
- Completion
- 2019-05-27
Publications
- Results Tsuchiya T, Imanaka K, Iwaki Y, Oyama R, Hashine K, Yamaguchi A, Uemura H. An open-label, phase 1 study of androgen receptor antagonist, apalutamide in Japanese patients with metastatic castration-resistant prostate cancer. Int J Clin Oncol. 2019 Dec;24(12):1596-1604. doi: 10.1007/s10147-019-01526-7. Epub 2019 Aug 24.
- Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 240 mg | Oral |