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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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Orlando Health, Inc.
Orlando, Florida, 32806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01903733
Pfizer
Recruiting
Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

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Pfizer Clinical Trials Contact Center

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[email protected]

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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
An Open-label Bosutinib Treatment Extension Study For Subjects With Chronic Myeloid Leukemia (Cml) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008
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.
Not Provided
Interventional
Not Provided
Masking: None (Open Label)
Chronic Myeloid Leukemia
Drug: bosutinib
The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 3, 2020
April 3, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Finland,   France,   Hong Kong,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Latvia,   Netherlands,   Peru,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Lithuania
 
NCT01903733
B1871040
2013-000691-15 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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