← Back to Search

Antiandrogen

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

Phase 2
Waitlist Available
Research Sponsored by Suzhou Kintor Pharmaceutical Inc,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 24 weeks, up to a maximum of 30 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug for men with prostate cancer that has spread and is resistant to other treatments. The objective is to find out if the new drug is safe and tolerated by patients.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 24 weeks, up to a maximum of 30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 24 weeks, up to a maximum of 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study.
Secondary study objectives
PSA Maximum Change at 12 Weeks
The Percentage of Subjects Achieving a ≥50% Reduction in PSA at 12 Weeks and 24 Weeks
Time to PSA Progression

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT03899467
53%
Fatigue
47%
Decreased appetite
43%
Constipation
33%
Weight decreased
23%
Oedema peripheral
23%
Nausea
23%
Fall
13%
Diarrhoea
13%
Asthenia
13%
Hot flush
10%
Vomiting
10%
Muscular weakness
10%
Anaemia
10%
Haematuria
10%
Dyspnoea
10%
Headache
7%
Confusional state
7%
Dizziness
7%
Hiccups
7%
Vision blurred
7%
Hypoglycaemia
7%
Arthralgia
7%
Insomnia
7%
Vertigo
7%
Dysgeusia
7%
Atrial fibrillation
3%
Neutropenic sepsis
3%
Dehydration
3%
Memory impairment
3%
COVID-19 pneumonia
3%
Febrile neutropenia
3%
Blood lactate dehydrogenase increased
3%
Anemia
3%
Neutropenia
3%
Hyponatraemia
3%
Pain in extremity
3%
Visual impairment
3%
Drug-induced liver injury
3%
Diverticulitis
3%
Urinary tract infection
3%
Back pain
3%
Abdominal pain
3%
Rhabdomyolysis
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: 500 mg/Day of GT0918
Arm 1: 400 mg /Day of GT0918

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GT0918
2019
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Suzhou Kintor Pharmaceutical Inc,Lead Sponsor
17 Previous Clinical Trials
3,810 Total Patients Enrolled
Phoebe Zhang, PhDStudy DirectorSuzhou Kintor Pharmaceuticals Inc
1 Previous Clinical Trials
40 Total Patients Enrolled
~9 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top