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Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

NCT01650805 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2014-11-17

Study results available
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Summary

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

ponatinib

45 mg tablet, taken orally once daily

DRUG

imatinib (Gleevec/ Glivec)

400 mg tablet, taken orally once daily

Sponsors & Collaborators

  • Ariad Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT01650805 on ClinicalTrials.gov