The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

Summary

This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment. The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies. Subjects will be randomized into the 2 treatment arms.

Timeline

Start

2019-05-30

Primary completion

2022-03-31

Completion

2022-09-19

Drugs

Indications