Trials / Active Not Recruiting
Active Not RecruitingNCT04279847
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.
Conditions
- Myelofibrosis
- Myelodysplastic Syndrome
- Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
- Myeloproliferative Neoplasm
- Relapsed or Refractory Primary Myelofibrosis
- Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)
- ET (Essential Thrombocythemia)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INCB057643 | INCB057643 dose escalation and dose expansion. |
| DRUG | Ruxolitinib | Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2. |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2020-02-21
- Last updated
- 2026-04-01
Locations
48 sites across 8 countries: United States, Canada, China, Finland, Italy, Japan, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04279847. Inclusion in this directory is not an endorsement.