Trial Details 29 Total Sites

A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

There are 4 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 participants with myeloproliferative neoplasm (MPN) or chronic myelomonocytic leukemia (CMML).

phase

Phase 1

status

Recruiting

enrollment

62

score

19

start date

2019-11-08

last updated

2021-12-22

biomarkers

N/A

Chicago, Illinois
facility
Northwestern University Feinberg School of Medicine /ID# 224203
1 facility
Recruiting
Louisville, Kentucky
facility
Norton Cancer Institute - St Matthews /ID# 239300
1 facility
Recruiting
Richmond, Virginia
facility
Virginia Commonwealth University Medical Center Main Hospital /ID# 228169
1 facility
Recruiting
Canton, Ohio
facility
Gabrail Cancer Center Research /ID# 228924
1 facility
Recruiting
Suita, Japan
facility
Osaka University Hospital /ID# 213235
1 facility
Recruiting
L'Hospitalet de Llobregat, Spain
facility
Hospital Duran i Reynals /ID# 224007
1 facility
Recruiting
Pamplona, Spain
facility
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 224839
1 facility
Recruiting
Kamakura, Japan
facility
Shonan Kamakura General Hospital /ID# 224315
1 facility
Recruiting
Woluwe-Saint-Lambert, Belgium
facility
UCL Saint-Luc /ID# 225314
1 facility
Recruiting
Bunkyo, Japan
facility
Juntendo University Hospital /ID# 213255
1 facility
Recruiting
Choshi, Japan
facility
University of Yamanashi Hospital /ID# 229279
1 facility
Recruiting
Ōsaka-sayama, Japan
facility
Kindai University Hospital /ID# 213241
1 facility
Recruiting