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Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01565668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-12-27

Study results available
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Summary

This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

AC220

oral

Sponsors & Collaborators

  • Ambit Biosciences Corporation

    collaborator INDUSTRY

  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States
  • France
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01565668 on ClinicalTrials.gov