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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

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NCT02228382

Last updated on December 6, 2018
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Study Location
Keck Hospital of USC
Los Angeles, California, 90033 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Previously Treated PH + CML
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

- Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed
BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative
Chronic Myeloid Leukemia (from initial diagnosis).

- Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib
and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).

- Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to
receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

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

- Participation in any other clinical studies involving investigational drug(s) within
14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
the first dose of bosutinib.

- Prior treatment with bosutinib.

- Prior treatment with ponatinib.

- Known T315I or V299L mutation.

NCT02228382
Pfizer
Active, not recruiting
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

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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
A Phase 4 Safety And Efficacy Study Of Bosutinib (Bosulif (Registered)) In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
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).
Not Provided
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Treatment
Previously Treated PH + CML
Drug: Bosutinib
100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Other Name: BOSULIF
Experimental: Bosutinib
Intervention: Drug: Bosutinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
163
September 18, 2021
September 18, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
  • Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
  • Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

Exclusion Criteria:

  • Participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib.
  • Prior treatment with bosutinib.
  • Prior treatment with ponatinib.
  • Known T315I or V299L mutation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Italy,   Norway,   Spain,   Sweden,   United States
Belgium,   Finland,   Netherlands
 
NCT02228382
B1871039
2013-003250-25 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Developmental Therapeutics Consortium
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

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