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NCT02915523 · ClinicalTrials.gov registry record · Phase 1
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
A Phase 1 study, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT02915523: Completed Phase 1 study, sponsored by Syndax Pharmaceuticals.
NCT02915523 is a Phase 1 study that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915523, a Phase 1 study, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose in terms of progression free survival compared to avelumab plus placebo in participants with refractory or recurrent epithelial ovarian cancer.
Primary Outcome
PFS was defined as the number of months from randomization to progressive disease (PD) or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm); the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions.
Interventions
- DRUG Placebo
- DRUG entinostat
- DRUG avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2016-12-19 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 1 |
What the finished NCT02915523 record still lists
NCT02915523 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02915523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915523 about?
NCT02915523 is a clinical study titled "Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer". The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose i...
What is the current status of trial NCT02915523?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2016-12-19. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT02915523?
The interventions under investigation include: Placebo (DRUG), entinostat (DRUG), avelumab (DRUG).
Who is sponsoring clinical trial NCT02915523?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02915523's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 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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