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Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses (OPTIC)
The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by \<=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 283 |
| Start date | Mon Jul 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Myeloid Leukemia, Chronic, Chronic Phase
Interventions
- Ponatinib
Countries
Hong Kong, Italy, Taiwan, Poland, South Korea, Denmark, Russia, Sweden, Portugal, United States, France, Chile, Argentina, Canada, Spain, United Kingdom, Germany, Switzerland, Australia, Singapore, Czechia