At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 283 enrolled
Drug / intervention
Ponatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
In Brief
A Phase 2 clinical trial evaluating Ponatinib for Myeloid Leukemia, Chronic, Chronic Phase. Completed, enrolled 283 participants across 86 sites in 21 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Leukemia, Chronic, Chronic Phase
CountriesArgentina, Australia, Canada, Chile, Czechia, Denmark, France, Germany, Hong Kong, Italy, Poland, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionApr 2020
Study CompletionApr 2025
TodayJul 2026
First PostedJun 10, 2015
Enrollment StartJul 13, 2015
Primary CompletionApr 29, 2020
Study CompletionApr 23, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.1 years ago
Interventions
Ponatinibdrug
Tablet, taken orally once daily.