SELECT-MDS-1
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients with Higher-risk Myelodysplastic Syndrome
IRAS ID
1004001
Contact name
Ashley Preston
Contact email
Sponsor organisation
Syros Pharmaceuticals, Inc
Eudract number
2020-004528-40
Clinicaltrials.gov Identifier
Research summary
SELECT-MDS-1 is a study to test how the investigational drug (tamibarotene) works in combination with azacitidine to treat higher-risk Myelodysplastic Syndrome (MDS) in patients who are newly diagnosed with a certain biomarker in their blood called RARA. There is a subset of patients with an overexpression of RARA and about 30% of MDS patients are RARA-positive. The purpose of this study is to find out if the study drug (tamibarotene) given in combination with standard of care (azacitidine) is better than the standard of care alone for treating MDS in RARA-positive patients. Patients will be randomized to one of two treatment arms. In one arm, participants will receive tamibarotene and azacitadine and in another arm, participants will receive placebo and azacitidine. Azacitidine will be given by IV infusion or subcutaneous injection on day 1 to 7, followed by tamibarotene given by mouth on days 8 – 28 of each 28-day cycle. Around 190 patients will be enrolled at approximately 136 sites worldwide.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0083
Date of REC Opinion
20 Jun 2022
REC opinion
Further Information Favourable Opinion