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Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

NCT02228382 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2021-12-30

Study results available
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Summary

The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).

Conditions

  • Previously Treated PH + CML

Interventions

DRUG

Bosutinib

100 mg and 500 mg tablets, once daily dosage up to 4 years duration

Sponsors & Collaborators

  • Developmental Therapeutics Consortium

    collaborator OTHER

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-07
Primary Completion
2020-10-13
Completion
2020-10-13

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Norway
  • Spain
  • Sweden

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 NCT02228382 on ClinicalTrials.gov