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NCT04556617 · ClinicalTrials.gov registry record · Phase 1
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1 study, sponsored by Opna Bio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04556617: Clinical Trial Phase 1 study, sponsored by Opna Bio.
NCT04556617 is a Phase 1 study that was terminated before completion, run by Opna Bio. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04556617, a Phase 1 study, was terminated before completion, sponsored by Opna Bio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Primary Outcome
Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Interventions
- DRUG Olaparib
- DRUG Prednisone
- DRUG Abiraterone acetate
- DRUG PLX2853 20 mg
- DRUG PLX2853 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 1 |
Why NCT04556617 stopped before completion
NCT04556617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Olaparib is the first listed.
NCT04556617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04556617 about?
NCT04556617 is a clinical study titled "PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)". The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
What is the current status of trial NCT04556617?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-09-21. Estimated completion is 2022-05-24.
What interventions are being tested in trial NCT04556617?
The interventions under investigation include: Olaparib (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG), PLX2853 20 mg (DRUG), PLX2853 40 mg (DRUG).
Who is sponsoring clinical trial NCT04556617?
This trial is sponsored by Opna Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04556617's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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