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

Pfizer

Status: Completed

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903733

B1871040

2013-000691-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design