Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer
Completed
Suzhou Kintor Pharmaceutical Inc,
Phase 1
This was a Phase 1, multicenter, open-label, clinical trial in adult subjects with metastatic
castrate resistant prostate cancer who progressed after both hormonal therapy (abiraterone or
enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either or both therapies.
The study involved a Phase 1 dose escalation of oral GT0918 to evaluate its safety,
tolerability, pharmacokinetics and pharmacodynamics.
the Safety and Tolerability of Proxalutamide (GT0918) in Subjects With Metastatic Castrate Resistant Prostate Cancer
Recruiting
Suzhou Kintor Pharmaceutical Inc,
Phase 2
This study is an open-label, randomized, expanded/phase II study in subjects with metastatic
castrate resistant prostate cancer (mCRPC) who progressed after either abiraterone or
enzalutamide.
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.
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
Completed
Beijing Cancer Hospital
Phase 1
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore
safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast
cancer.
This study includes two stages, stage I: single- and multiple-dose tolerance and
pharmacokinetic study; stage 2: preliminary efficacy and safety study.
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