A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT01390337 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-02-12

No results posted yet for this study

Summary

The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

AC220

Oral Liquid

DRUG

daunorubicin

Intravenous Infusion

DRUG

cytarabine

Intravenous Infusion

Sponsors & Collaborators

  • Ambit Biosciences Corporation

    collaborator INDUSTRY
  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Guy Gammon, MB, BS, MRCP · Medical Monitor, Ambit Biosciences Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

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 NCT01390337 on ClinicalTrials.gov