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

NCT02343939 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2019-11-15

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2018-09-04
Completion
2019-02-21
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343939 on ClinicalTrials.gov