A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
Active, not recruiting · Phase 1 · NCT04041050
Conditions: Myeloproliferative Neoplasm
At a glance
- Research payments reported, 2025
- $90,392
- U.S. investigators named
- 6
- Sites paid
- 9
- Planned or actual enrollment
- 85
About the trial
- Sponsor
- AbbVie
- Tested
- Navitoclax (drug), Ruxolitinib (drug), Celecoxib (drug)
- Dates
- Started 2019-11-08; completion 2026-12-31
- Results posted
- Not yet
There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxol…
From ClinicalTrials.gov, last updated 2025-02-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $90,392 in research payments for this study in 2025 (19 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Michael Y. Choi, M.D. Hematology & Oncology · San Diego, CA
- Roy L. Panares, MD Hematology & Oncology · Fullerton, CA
- Vinod Pullarkat, M.D. Hematology · Duarte, CA
- Don A. Stevens, M.D. Medical Oncology · Louisville, KY
- Satish A. Shah, M.D. Hematology & Oncology · Gettysburg, PA
- Keri R. Maher, D.O. Medical Oncology · Richmond, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Virginia Commonwealth University School of Medicine $39,247
- Regents of the Univ of California $22,836
- Norton Healthcare Inc $12,119
- St Joseph Heritage Healthcare $8,725
- City of Hope National Medical Ctr $3,750
- Pennsylvania Cancer Specialists & Research Institute $1,616
- University of California San Diego Jacobs Medical Center $875
- Pennsylvania Cancer Specialist and Research Institute $700
- Norton Hospital $525
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.