A Phase I/II Study of GSK3326595 in People with Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia

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Full Title

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 Leukemia

Purpose

The purpose of this study is to find the highest dose of the investigational drug GSK3326595 that can be given to patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). GSK3326595 blocks two proteins that can cause cancer cell growth: PRMT5 and MEP50. By blocking PRMT5 and MEP50, GSK3326595 may slow or stop cancer growth. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MDS, CMML, or AML that persists despite prior treatment.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Virginia Klimek at 212-639-6519.

Protocol

20-017

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators