The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Suzhou Kintor Pharmaceutical Inc,
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
PZ
Phoebe Zhang, PhD
Principal Investigator
Suzhou Kintor Pharmaceuticals Inc
Eligibility Criteria
Inclusion Criteria
Signed informed consent obtained prior to any study-related procedure being performed.
Subjects at least 18 years of age or older at the time of consent.
Subjects with histologically confirmed metastatic castrate resistant prostate cancer (mCRPC) who progressed after abiraterone or enzalutamide.
See 7 more
Treatment Details
Interventions
- Proxalutamide (GT0918) (Antiandrogen)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: 500 mg/day of GT0918Experimental Treatment1 Intervention
Group 1: Post enzalutamide failure
Group 2: Post abiraterone failure
Group II: Arm 1: 400 mg /day of GT0918Experimental Treatment1 Intervention
Group 1: Post enzalutamide failure
Group 2: Post abiraterone failure
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
G U Research NetworkOmaha, NE
New York Cancer & Blood SpecialistsBronx, NY
New York Cancer & Blood SpecialistsEast Setauket, NY
Gabrail Cancer Center ResearchCanton, OH
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Suzhou Kintor Pharmaceutical Inc,
Lead Sponsor
Trials
18
Patients Recruited
3,900+