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NCT02987829 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients
A Phase 1 study, sponsored by Tracon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT02987829: Completed Phase 1 study, sponsored by Tracon Pharmaceuticals.
NCT02987829 is a Phase 1 study that has completed, run by Tracon Pharmaceuticals. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02987829, a Phase 1 study, has completed, sponsored by Tracon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansion).
Primary Outcome
The trial began with single patient dose escalation rules. If 1 of 1 patients at a given dose experienced a DLT, the study transitioned to a 3+3 design. If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC253 during the firs
Interventions
- DRUG TRC253
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2020-11-09 |
| Phase | Phase 1 |
What the finished NCT02987829 record still lists
NCT02987829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which TRC253 is the first listed.
NCT02987829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02987829 about?
NCT02987829 is a clinical study titled "Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients". This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansi...
What is the current status of trial NCT02987829?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2017-05-23. Estimated completion is 2020-11-09.
What interventions are being tested in trial NCT02987829?
The interventions under investigation include: TRC253 (DRUG).
Who is sponsoring clinical trial NCT02987829?
This trial is sponsored by Tracon Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02987829's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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