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NCT02708680 · ClinicalTrials.gov registry record · Phase 1
Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
A Phase 1 study, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT02708680: Completed Phase 1 study, sponsored by Syndax Pharmaceuticals.
NCT02708680 is a Phase 1 study that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02708680, a Phase 1 study, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in participants with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in participants with aTNBC.
Primary Outcome
Phase 1b employed a classical 3+3 design, with the determination of DLT based on entinostat in combination with atezolizumab within the first cycle of treatment (that is, between Day 1 to Day 21 of Cycle 1). Six participants were required to be treated in a dose level for it to be considered MTD or the Recommended Phase 2 Dose (RP2D). A DLT was defined as the occurrence of specific events, defined in the protocol, that were considered by the investigator to be at least possibly related to study
Interventions
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2016-05 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 1 |
What the finished NCT02708680 record still lists
NCT02708680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02708680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02708680 about?
NCT02708680 is a clinical study titled "Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In". The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in participants with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combinat...
What is the current status of trial NCT02708680?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2016-05. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT02708680?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT02708680?
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 NCT02708680's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 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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