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Bosutinib Treatment Extension...

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

NCT ID: NCT01903733

Last Updated: 2022-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-28

Study Completion Date

2020-06-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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bosutinib

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.

Exclusion Criteria

* All subjects are excluded unless previously participating in studies B1871006 or B1871008.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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