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Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

NCT01903733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2022-07-19

Study results available
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Summary

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

bosutinib

The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-28
Primary Completion
2020-06-05
Completion
2020-06-05

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Finland
  • France
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Latvia
  • Netherlands
  • Peru
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT01903733 on ClinicalTrials.gov