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NCT03899467 · ClinicalTrials.gov registry record · Phase 2
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
A Phase 2 study, sponsored by Suzhou Kintor Pharmaceutical Inc,.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03899467: Completed Phase 2 study, sponsored by Suzhou Kintor Pharmaceutical Inc,.
NCT03899467 is a Phase 2 study that has completed, run by Suzhou Kintor Pharmaceutical Inc,. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03899467, a Phase 2 study, has completed, sponsored by Suzhou Kintor Pharmaceutical Inc,.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To evaluate the safety and tolerability of GT0918 assessed by AEs, SAEs between 400 mg arm vs. 500 mg arm with mHSPC or mCRPC who failed either abiraterone or enzalutamide treatment The percetage of AE and SAE would be evaluated in subjects with mHSPC and to determine the recommended Phase II dose (RP2D) over 6 months or longer treatment
Interventions
- DRUG GT0918
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2022-09-19 |
| Phase | Phase 2 |
What the finished NCT03899467 record still lists
NCT03899467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which GT0918 is the first listed.
NCT03899467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03899467 about?
NCT03899467 is a clinical study titled "The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC". 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 determi...
What is the current status of trial NCT03899467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2019-05-30. Estimated completion is 2022-09-19.
What interventions are being tested in trial NCT03899467?
The interventions under investigation include: GT0918 (DRUG).
Who is sponsoring clinical trial NCT03899467?
This trial is sponsored by Suzhou Kintor Pharmaceutical Inc,, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03899467's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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