At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 4 enrolled
Drug / intervention
itacitinibdrug
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 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
In Brief
A Phase 2 clinical trial evaluating itacitinib for Myelofibrosis and 2 related conditions. Completed, enrolled 4 participants across 21 sites in 7 countries.
Detailed Summary
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis, Polycythemia Vera, Thrombocythemia
CountriesAustria, Belgium, Germany, Italy, Poland, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartJul 2021
Primary CompletionAug 2023
TodayJul 2026
First PostedNov 16, 2020
Enrollment StartJul 12, 2021
Primary CompletionAug 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.6 years ago
Interventions
itacitinibdrug
itacitinb Immediate Release (IR) will be dosed orally twice a day