A Phase I/II study to investigate the safety and clinical activity of GSK3326595 and other agents in subjects with myelodysplastic syndrome and acute myeloid leukaemia.

Protocol No
GSK-208809
Principal Investigator
Sameem Abedin
Phase
I/II
Summary
GSK3326595 is a potent, selective, reversible inhibitor of the protein arginine methyltransferase 5 (PRMT5)/Methylosome protein 50 (MEP50) complex that is being tested as an oral treatment for human subjects with cancer. Myelodysplastic syndrome and acute myeloid leukaemia are bone marrow neoplasms for which novel, effective therapies are desperately needed. This is an open-label, multicentre, multi-part study to evaluate the safety, tolerability, and clinical activity of GSK3326595 in subjects with relapsed and refractory MDS, chronic myelomonocytic leukaemia (CMML), and hypoproliferative AML that has evolved from an antecedent MDS Part 2A is a randomized head-to-head Phase II evaluation of GSK3326595 compared to investigator's choice of best available care (BAC). Part 2B is composed of an abbreviated series of dose escalation cohorts followed by a single-arm dose expansion cohort to determine the overall response rate of the combination of GSK3326595 plus 5-azaciditine in newly-diagnosed MDS. Part 2C is a single-arm dose expansion study to evaluate the clinical activity of single-agent GSK3326595 in subjects with AML whose disease contains mutations in spliceosome proteins.
Description
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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