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NCT02374099 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT02374099: Clinical Trial Phase 2 study, sponsored by Celgene.
NCT02374099 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02374099, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).
Primary Outcome
Progression-free survival was defined as the duration from the date of randomization to the date of disease progression (DP) based on investigator's assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or death (from any cause), whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Interventions
- DRUG Fulvestrant
- DRUG CC-486
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2015-03-13 |
| Est. Completion | 2017-11-21 |
| Phase | Phase 2 |
Why NCT02374099 stopped before completion
NCT02374099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT02374099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02374099 about?
NCT02374099 is a clinical study titled "Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant". The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Ha...
What is the current status of trial NCT02374099?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2015-03-13. Estimated completion is 2017-11-21.
What interventions are being tested in trial NCT02374099?
The interventions under investigation include: Fulvestrant (DRUG), CC-486 (DRUG).
Who is sponsoring clinical trial NCT02374099?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02374099's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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