Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | November 7, 2014 |
| End Date: | September 18, 2021 |
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).
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).
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.
We found this trial at
16
sites
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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