FDA temporarily suspended a phase 1 clinical trial (NCT04734990) evaluating seclidemstat (SP-2577) in combination with azacitidine for treating myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
This action follows the reporting of a severe and unexpected grade 4 adverse event (AE) by investigators at The University of Texas MD Anderson Cancer Center in Houston, Texas.
This partial hold for seclidemstat ensures no new patients with MDS/CMML were enrolled in the trial while a thorough investigation into the reported AE is conducted.
The FDA emphasized that patients with MDS/CMML already participating in the trial could continue receiving seclidemstat treatment if their doctors determined they were experiencing clinical benefits.
Additionally, seclidemstat, an oral LSD1 inhibitor, was granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation for treating Ewing sarcoma.
The phase 1/2 trial aimed to determine the optimal dosage of seclidemstat when combined with azacitidine for patients with MDS or CMML.
Source: FDA Enforces Partial Hold on Trial of Seclidemstat in MDS/CMML
https://www.targetedonc.com/view/fda-enforces-partial-hold-on-trial-of-seclidemstat-in-mds-cmml
