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NCT02807558 · ClinicalTrials.gov registry record · Phase 2
A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 2 study, sponsored by Syros Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
NCT02807558: Completed Phase 2 study, sponsored by Syros Pharmaceuticals.
NCT02807558 is a Phase 2 study that has completed, run by Syros Pharmaceuticals. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02807558, a Phase 2 study, has completed, sponsored by Syros Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the activity of tamibarotene in participants with relapsed/refractory (R/R) AML (administered as a monotherapy or in combination with azacitidine), R/R higher-risk MDS (HR-MDS) (administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML participants who are unlikely to tolerate standard intensive chemotherapy (administered as a monotherapy or in combination with azacitidine), or lower-risk MDS (LR-MDS) (administered as a monotherapy).
Primary Outcome
ORR was defined as: AML: number of participants with complete remission (CR), CR with incomplete blood count recovery (CRi), CR with partial hematologic recovery (CRh), partial remission(PR), or morphologic leukemia-free state (MLFS) determined by the investigator per revised International Working Group (IWG) AML criteria. HR-MDS: the number of participants with CR, PR, marrow CR (mCR), or HI determined by the investigator per revised IWG MDS criteria.
Interventions
- DRUG Azacitidine
- DRUG Daratumumab
- DRUG Tamibarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2016-09-20 |
| Est. Completion | 2023-01-25 |
| Phase | Phase 2 |
What the finished NCT02807558 record still lists
NCT02807558 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT02807558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02807558 about?
NCT02807558 is a clinical study titled "A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome". The purpose of this study is to determine the activity of tamibarotene in participants with relapsed/refractory (R/R) AML (administered as a monotherapy or in combination with azacitidine), R/R higher-risk MDS (HR-MDS) (administered as a monotherapy or in combination with daratumumab), newly diagnos...
What is the current status of trial NCT02807558?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2016-09-20. Estimated completion is 2023-01-25.
What interventions are being tested in trial NCT02807558?
The interventions under investigation include: Azacitidine (DRUG), Daratumumab (DRUG), Tamibarotene (DRUG).
Who is sponsoring clinical trial NCT02807558?
This trial is sponsored by Syros Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02807558's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 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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