Status:
TERMINATED
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Developmental Therapeutics Consortium
Conditions:
Previously Treated PH + CML
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 Philadel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT02228382
Start Date
November 7 2014
End Date
October 13 2020
Last Update
December 30 2021
Active Locations (48)
Enter a location and click search to find clinical trials sorted by distance.
1
Keck Hospital of USC
Los Angeles, California, United States, 90033
2
LAC+USC Medical Center
Los Angeles, California, United States, 90033
3
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Sylvester Deerfield Beach
Deerfield Beach, Florida, United States, 33442