Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06773195 | A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis | PHASE1 | RECRUITING | 37 | — | — | Jan 7, 2025 | Jan 1, 2028 | Apr 3, 2026 | 9 | United States |
If none of the initial 3 patients in a cohort experience a dose limiting toxicity (DLT), then the next dose level will be studied in another cohort of 3 patients. If 1 of the initial 3 patients at a given dose level experience a DLT, up to 3 additional patients will be treated at that same dose level. Escalation will continue if not more than 1 of the 6 patients experience a DLT.
as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT working criteria)
| Arm | Type | Description |
|---|---|---|
| JAK/MEK inhibition with Ruxolitinib and Ulixertinib | EXPERIMENTAL | Phase 1: There are 3 planned dose levels of ulixertinib (450 mg BID, 300 mg BID, or 150 mg BID) in combination with ruxolitinib for 28 day cycles. A 3+3 dose escalation design will be used to determine the RP2D of ulixertinib with ruxolitinib. Phase 2: Participants will be treated with ulixertinib at the RP2D determined from the phase 1 part of the study in combination with ruxolitinib for 28 day cycles. |
| Name | Type | Description |
|---|---|---|
| Ulixertinib | DRUG | There are 3 planned dose levels of ulixertinib(450 mg BID, 300 mg BID, or 150 mg BID) |
| Ruxolitinib | DRUG | Ruxolitinib for 28 day cycles. |
Inclusion Criteria: * Patients with a diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016 criteria. * Age ≥18 years. * Receiving ruxolitinib monotherapy for at least 3 months with stable dose (10 mg BID to 20mg BID) for at...