The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
Public ClinicalTrials.gov record NCT03899467. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC Who Failed Either Abiraterone or Enzalutamide
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03899467
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2019 (Actual)
- Primary completion
- Mar 31, 2022 (Actual)
- Completion
- Sep 19, 2022 (Actual)
- Last update posted
- Feb 12, 2024
2019 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Cancer & Blood Center | Athens | Georgia | 30607 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| G U Research Network | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| New York Cancer & Blood Specialists | East Setauket | New York | 11733 | — |
| New York Cancer & Blood Specialists | The Bronx | New York | 10469 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03899467, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 12, 2024 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03899467 live on ClinicalTrials.gov.