CLINICAL TRIALS PROFILE FOR PROXALUTAMIDE

Clinical Trials for Proxalutamide

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02826772 ↗	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.
NCT03899467 ↗	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.
NCT04103853 ↗	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.
NCT04103853 ↗	Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer	Completed	Hebei Medical University Fourth 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.

Clinical Trial Conditions for Proxalutamide

Condition Name

Condition Name
Intervention	Trials
Covid19	4
SARS (Severe Acute Respiratory Syndrome)	3
COVID-19	3
Metastatic Castrate Resistant Prostate Cancer (mCRPC)	2

Condition MeSH

Condition MeSH
Intervention	Trials
COVID-19	7
Coronavirus Infections	4
Severe Acute Respiratory Syndrome	4
Prostatic Neoplasms	3

Clinical Trial Locations for Proxalutamide

Trials by Country

Trials by Country
Location	Trials
United States	24
China	8
Brazil	7

Trials by US State

Trials by US State
Location	Trials
Texas	2
South Carolina	2
Georgia	2
Ohio	2
New York	2

Clinical Trial Progress for Proxalutamide

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	6
Completed	5
Active, not recruiting	1

Clinical Trial Sponsors for Proxalutamide

Sponsor Name

Sponsor Name
Sponsor	Trials
Suzhou Kintor Pharmaceutical Inc,	6
Applied Biology, Inc.	4
Ruijin Hospital	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Other	14
Industry	11