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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02370706 | Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis | PHASE1 | COMPLETED | 15 | — | — | May 21, 2015 | Nov 9, 2020 | Feb 9, 2022 | 9 | Australia, Canada +6 |
To estimate the maximum tolerated dose and/or recommended dose for expansion for each of the following three treatment arms in patients with myelofibrosis (MF): PIM447 plus ruxolitinib (doublet), LEE011 plus ruxolitinib (doublet), PIM447 plus ruxolitinib and LEE 011 (triple combination).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm 1 | EXPERIMENTAL | - |
| Dose Escalation Arm 2 | EXPERIMENTAL | - |
| Dose Escalation Arm 3 | EXPERIMENTAL | - |
| Dose Expansion Arm 1 | EXPERIMENTAL | - |
| Dose Expansion Arm 2 | EXPERIMENTAL | - |
| Dose Expansion Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PIM447 | DRUG | pan-pim inhibitor |
| Ruxolitinib | DRUG | JAK1/JAK2 inhibitor |
| LEE011 | DRUG | CDK4/6 inhibitor |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Patient must be diagnosed with JAK2V617F-positive primary or secondary MF. * Dose-escalation and Expansion parts: Patients with a \< 35% reduction in spleen volume by MRI/CT or \< 50% reduction in spleen si...