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

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

Eligibility Criteria

Inclusion Criteria:

- Adults with AML in need of treatment (except individuals with acute promyelocytic
leukemia M3)

- Group A: Individuals > 18 years of age with previously untreated AML who are able to
receive cytarabine amd daunorubicin (7+3) chemotherapy as determined by the treating
physician

- Group B: Individuals > 70 years of age with previously untreated AML or individuals <
70 years of age with previously untreated AML who refuse or are unable to receive
cytarabine as determined by the treating physician

- Group C: Individuals > 18 years of age with relapsed or refractory AML by WHO
criteria or individuals with previously untreated AML who would have met eligibility
criteria for Groups A or B but refuse or are unable to receive chemotherapy as
determined by the treating physician

Exclusion Criteria:

- Known active central nervous system or leptomeningeal lymphoma

Principal Investigator

Mario Marcondes, MD, PhD

Study Contact

Gilead Study Team, GS9973alerts@gilead.com

Estimated Completion Date

Wednesday, November 1, 2017

ClinicalTrials.gov #

NCT02343939
10/17/2016