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Trial Summary

Protocol No.GS-US-339-1559
StatusOPEN TO ACCRUAL
Principal InvestigatorKonig, Heiko
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Subjects with Acute Myeloid Leukemia (AML)
DescriptionThis 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).
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Adults with AML in need of treatment (except individuals with acute promyelocytic leukemia M3)
  • Individuals > 70 years of age with previously untreated AML
  • Individuals ≤ 70 years of age with previously untreated AML who refuse or are unable to receive daunorubicin and cytarabine (3+7) chemotherapy as determined by the treating physician
  • Individuals ≥ 18 and < 60 years of age with previously untreated AML by World Health Organization (WHO) criteriaIndividuals between 60 to 70 years of age are eligible regardless of risk group
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLeukemia (Adult)
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment