Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

Stopped early · Phase 4

Conditions studied: Previously Treated PH + CML

In brief

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).

Key facts

Study ID

NCT02228382

Run by

Pfizer

People needed

163

Starts

2014-11-07

Expected to finish

2020-10-13

Last updated by the study team

2021-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Keck Hospital of USC — Los Angeles, California, United States
• LAC+USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Sylvester Deerfield Beach — Deerfield Beach, Florida, United States
• University of Miami Hospital & Clinics — Miami, Florida, United States
• Indiana Blood and Marrow Transplantation-Clinic — Indianapolis, Indiana, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Siteman Cancer Center - South County — St Louis, Missouri, United States
• Weill Cornell Medical College - New York-Presbyterian Hospital — New York, New York, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Medizinische Universitaet Innsbruck — Innsbruck, Austria
• Ordensklinikum Linz Gmbh Barmherzige Schwestern — Linz, Austria
• Institut Bergonie — Bordeaux, France
• Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology — Le Chesnay, France
• Centre Regional De Lutte Contre Le Cancer — Marseille, France
• Hopital Archet I — Nice, France
• Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse, France
• CHU Brabois — Vandœuvre-lès-Nancy, France
• RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation — Aachen, Germany
• Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) — Berlin, Germany
• Universitaetsklinikum Koeln (AoeR) — Cologne, Germany
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany

Full record on ClinicalTrials.gov

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