Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

Official Title

A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia (AML)

Summary:

This study will evaluate the efficacy, safety, and tolerability of entospletinib (GS-9973) when administered as monotherapy or in combination with chemotherapy in adults with acute myeloid leukemia (AML).

Trial Description

Primary Outcome:

  • Occurrence of adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLTs) for each treatment group
  • Complete remission rate at induction completion
  • Composite complete remission rate at induction completion
  • Overall response rate at induction completion
Secondary Outcome:
  • Study drug administration
  • Duration of exposure of study treatment
  • Occurrence of AEs and laboratory abnormalities not defined as DLTs
  • Event free survival (EFS)
  • Overall survival (OS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society