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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04454658 | Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis | PHASE1 | ACTIVE NOT_RECRUITING | 21 | — | — | Nov 11, 2020 | Jan 1, 2027 | Jul 16, 2025 | 43 | United States, Argentina +12 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
| Arm | Type | Description |
|---|---|---|
| Segment A: ABBV-744 Dose Identification and Optimization | EXPERIMENTAL | Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of ABBV-744 to identify the safe dosing regimen and schedule. |
| Segment A: ABBV-744 Monotherapy | EXPERIMENTAL | Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy. |
| Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy | EXPERIMENTAL | Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy. |
| Segment C: ABBV-744 + Navitoclax | EXPERIMENTAL | Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax. |
| Segment D: ABBV-744 + Ruxolitinib | EXPERIMENTAL | Participants who have never received JAKi will receive ABBV-744 and ruxolitinib. |
| Name | Type | Description |
|---|---|---|
| ABBV-744 | DRUG | Tablet; Oral |
| Navitoclax | DRUG | Tablet; Oral |
| Ruxolitinib | DRUG | Tablet; Oral |
Inclusion Criteria: * Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria. * Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score \>=3 or a total sc...