NCT02343939

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Entospletinib	Tablet(s) administered orally every 12 hours
DRUG	Daunorubicin	60 mg/m\^2 administered intravenously daily on Days 1 to 3 for up to two 14-day induction cycles
DRUG	Cytarabine	100 mg/m\^2 administered intravenously daily on Days 1 to 7 for up to two 14-day cycles
DRUG	Decitabine	20 mg/m\^2 administered intravenously
DRUG	Azacitidine	75 mg/m\^2 administered intravenously or subcutaneously

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-09-04
• Completion: 2019-02-21
• First posted: 2015-01-22
• Last updated: 2019-11-15
• Results posted: 2019-11-15

Locations

17 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study