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NCT04493619 · ClinicalTrials.gov registry record · Phase 1
PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer
A Phase 1 study, sponsored by Opna Bio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT04493619: Clinical Trial Phase 1 study, sponsored by Opna Bio.
NCT04493619 is a Phase 1 study that was terminated before completion, run by Opna Bio. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493619, a Phase 1 study, was terminated before completion, sponsored by Opna Bio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 37 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 Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.
Primary Outcome
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Interventions
- DRUG Carboplatin
- DRUG PLX2853
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2022-04-25 |
| Phase | Phase 1 |
Why NCT04493619 stopped before completion
NCT04493619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT04493619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493619 about?
NCT04493619 is a clinical study titled "PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer". The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial O...
What is the current status of trial NCT04493619?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-08-11. Estimated completion is 2022-04-25.
What interventions are being tested in trial NCT04493619?
The interventions under investigation include: Carboplatin (DRUG), PLX2853 (DRUG).
Who is sponsoring clinical trial NCT04493619?
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 NCT04493619's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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