GT0918

DRUG3 trials

Sponsors

Suzhou Kintor Pharmaceutical Inc,

Conditions

Covid19Metastatic Castrate Resistant Prostate Cancer (mCRPC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Phase 1

Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer

CompletedNCT02826772

Suzhou Kintor Pharmaceutical Inc,Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Start: 2016-02-10End: 2020-02-15Updated: 2020-03-17

Phase 2

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

CompletedNCT03899467

Suzhou Kintor Pharmaceutical Inc,Metastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Start: 2019-05-30End: 2022-09-19Updated: 2024-02-12

Phase 3

A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

TerminatedNCT05009732

Suzhou Kintor Pharmaceutical Inc,Covid19

Start: 2021-09-30End: 2023-07-14Updated: 2023-08-18

Related Papers

Preliminary analysis of a U.S. phase II study of the safety and tolerability of proxalutamide (GT0918) in subjects with mCRPC who had progressed on either abiraterone (Abi) or enzalutamide (Enza).

Journal of Clinical Oncology2021-02-202 citations

Randomized multicenter open-label trial of GT0918 (proxalutamide) in patients with mCRPC that progressed on abiraterone or enzalutamide.

Journal of Clinical Oncology2020-05-20

Biomarker analysis (CTC and ctDNA/RNA) of GT0918 (Proxalutamide) new AR blocker in phase I mCRPC patients with dose escalation.

Journal of Clinical Oncology2020-02-19

Abstract 3885: Evaluation of pharmacokinetics of proxalutamide, a novel androgen receptor antagonist, in treatment for mCRPC patients via CTC enumeration and AR biomarker analysis

Cancer Research2019-07-011 citations

Abstract 3885: Evaluation of pharmacokinetics of proxalutamide, a novel androgen receptor antagonist, in treatment for mCRPC patients via CTC enumeration and AR biomarker analysis

Experimental and Molecular Therapeutics2019-07-01

Safety and clinical outcomes of GT0918 (Proxalutamide), a potent androgen receptor (AR) blocker, in patients with mCRPC progressing on standard (SoC) and experimental therapies: Phase I/II trial.

Journal of Clinical Oncology2019-05-201 citations

A phase I/II study of proxalutamide (GT0918), a potent androgen receptor blocker, in patients with mCRPC progressed after both hormonal therapy and chemotherapy.

Journal of Clinical Oncology2019-03-013 citations

Plasma-based exploratory biomarker analysis to evaluate GT0918 in a phase I/II study in mCRPC patients.

Journal of Clinical Oncology2019-03-011 citations

Circulating tumor DNA and RNA as an exploratory biomarker to evaluate GT0918 in a phase I/II clinical trial in mCRPC patients

Annals of Oncology2018-10-011 citations