Clinical Trial: NCT02467270
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Takeda |
| Information Provided By: | Takeda |
| Last Update Posted: | 2026-03-17 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Ponatinib
Other Study ID Numbers
- AP24534-14-203
- 2014-001617-12
- 15/LO/1192
- U1111-1238-0007
- 2024-514516-27-00
- 2014
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Takeda |
| Information Provided By: | Takeda |
| Last Update Posted: | 2026-03-17 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Ponatinib
Other Study ID Numbers
- AP24534-14-203
- 2014-001617-12
- 15/LO/1192
- U1111-1238-0007
- 2024-514516-27-00
- 2014