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NCT02826772 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer
A Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC), sponsored by Suzhou Kintor Pharmaceutical Inc,.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 6
- Study locations
NCT02826772: Completed Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC), sponsored by Suzhou Kintor Pharmaceutical Inc,.
NCT02826772 is a Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC) that has completed, run by Suzhou Kintor Pharmaceutical Inc,. The registered enrollment target is 40 participants, below the 237-participant average among 3 other Metastatic Castrate Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (83% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02826772, a Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC), has completed, sponsored by Suzhou Kintor Pharmaceutical Inc,.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
abnormal laboratory value
Conditions Studied
Interventions
- DRUG GT0918
Study Locations (6)
Maryland
- Chesapeake Urology Research Associates - Towson
Nebraska
- G U Research Network - Omaha
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
New Jersey
- Rutgers University - New Brunswick
New York
- North Shore Hematology Oncology Associates - East Setauket
Ohio
- Gabrail Cancer Center Research - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-02-10 |
| Est. Completion | 2020-02-15 |
| Phase | Phase 1 |
What the finished NCT02826772 record still lists
NCT02826772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 237-participant average among 3 other Metastatic Castrate Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Metastatic Castrate Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 1 intervention - of which GT0918 is the first listed.
NCT02826772 lists 6 locations in 6 states (Maryland, Nebraska, Nevada).
Frequently Asked Questions
What is clinical trial NCT02826772 about?
NCT02826772 is a clinical study titled "Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer". 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 P...
What is the current status of trial NCT02826772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-02-10. Estimated completion is 2020-02-15.
What conditions does trial NCT02826772 study?
This clinical trial studies the following conditions: Metastatic Castrate Resistant Prostate Cancer (mCRPC).
What interventions are being tested in trial NCT02826772?
The interventions under investigation include: GT0918 (DRUG).
Who is sponsoring clinical trial NCT02826772?
This trial is sponsored by Suzhou Kintor Pharmaceutical Inc,, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02826772 being conducted?
This trial has 6 study locations across Maryland, Nebraska, Nevada, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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