CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
Tamibarotene +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02807558
NCT02807558Phase 2Completed

A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Syros Pharmaceuticals·interventional·Posted Jun 21, 2016·Updated Dec 13, 2024

In Brief

A Phase 2 clinical trial evaluating Tamibarotene, Azacitidine, and 1 other intervention for Acute Myeloid Leukemia and Myelodysplastic Syndrome. Completed, enrolled 155 participants across 26 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 21, 2016
Enrollment StartSep 20, 2016
Primary CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.0 years ago

Interventions

Tamibarotenedrug

Administered as oral tablets

Azacitidinedrug

Administered via intravenous (IV) or subcutaneous (SC) infusion

Daratumumabdrug

Administered via IV infusion