A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
← catalyst calendarNCT04041050 · readout in 134 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
85actual
Sites
42
Countries
Belgium, Bulgaria, Croatia +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-11-08 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-08-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-02-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myeloproliferative Neoplasm
Interventions
- Drug: Navitoclax — also filed as ABT-263
- Drug: Ruxolitinib
- Drug: Celecoxib — also filed as Celebrex
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Dose Limiting Toxicities (DLT) (Part 1 and Part 2)
measured Up to 28 days after the navitoclax initiation
Maximum Observed Plasma Concentration (Cmax) of Navitoclax (Part 2 and 5)
measured Up to approximately 1 day
Maximum Observed Plasma Concentration (Cmax) of Celecoxib (Part 4)
measured Up to approximately 1 day
Time to Cmax (peak time, Tmax) of Navitoclax (Part 2 and 5)
measured Up to approximately 1 day
Time to Cmax (peak time, Tmax) of Celecoxib (Part 4)
measured Up to approximately 1 day
Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Navitoclax
measured Up to approximately 2 days
Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Celecoxib (Part 4)
measured Up to approximately 2 days
Number of Participants with Adverse Events
measured From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
Change in QT interval corrected for heart rate interval by Fridericia's correction formula (QTcF) (Part 3)
measured From first dose of study drug until 30 days following last dose of study drug.
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