Spots Global Cancer Trial Database for A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
Official Title: A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Myeloproliferative Neoplasm Subjects
Study ID: NCT04041050
Conditions
Study Description
Brief Summary: 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 ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope /ID# 239769, Duarte, California, United States
Providence Medical Foundation /ID# 242558, Fullerton, California, United States
Moores Cancer Center at UC San Diego /ID# 229584, La Jolla, California, United States
UCLA /Id# 222784, Los Angeles, California, United States
Northwestern University Feinberg School of Medicine /ID# 224203, Chicago, Illinois, United States
Norton Cancer Institute - St Matthews /ID# 239300, Louisville, Kentucky, United States
Brigitte Harris Cancer Pavilion /ID# 238686, Detroit, Michigan, United States
Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 242554, Omaha, Nebraska, United States
East Carolina University Brody School of Medicine /ID# 238560, Greenville, North Carolina, United States
Gabrail Cancer Center Research /ID# 228924, Canton, Ohio, United States
Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550, Gettysburg, Pennsylvania, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 228169, Richmond, Virginia, United States
UCL Saint-Luc /ID# 225314, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
UMHAT Sveti Georgi /ID# 240022, Plovdiv, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 240077, Sofia, , Bulgaria
Klinicki bolnicki centar Zagreb /ID# 240140, Zagreb, Grad Zagreb, Croatia
Centre Antoine Lacassagne - Nice /ID# 242293, Nice, Alpes-Maritimes, France
CHU Amiens-Picardie Site Sud /ID# 240792, Amiens CEDEX 1, Somme, France
AP-HP - Hopital Saint-Louis /ID# 240685, Paris, , France
IUCT Oncopole /ID# 242353, Toulouse Cedex 9, , France
Universitaetsklinikum Freiburg /ID# 222791, Freiburg, Baden-Wuerttemberg, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 224835, Berlin, , Germany
Klinikum Kassel /ID# 225440, Kassel, , Germany
Universitaetsmedizin Rostock /ID# 225436, Rostock, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 221408, Rome, Lazio, Italy
ASST Spedali civili di Brescia /ID# 224962, Brescia, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 224071, Meldola, , Italy
Shonan Kamakura General Hospital /ID# 224315, Kamakura-shi, Kanagawa, Japan
Kindai University Hospital /ID# 213241, Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 213235, Suita-shi, Osaka, Japan
Juntendo University Hospital /ID# 213255, Bunkyo-ku, Tokyo, Japan
University of Yamanashi Hospital /ID# 229279, Chuo-shi, Yamanashi, Japan
University Clinical Center Serbia /ID# 240674, Belgrade, Beograd, Serbia
Hospital Duran i Reynals /ID# 224007, Hospitalet de Llobregat, Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 224839, Pamplona, Navarra, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 226041, Madrid, , Spain
Linkoping University Hospital /ID# 239995, Linkoping, , Sweden
Karolinska University Hospital /ID# 239992, Stockholm, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215631, Kaohsiung, , Taiwan
China Medical University Hospital /ID# 215634, Taichung City, , Taiwan
Dokuz Eylul University Medical Faculty /ID# 239952, Izmir, , Turkey
Gloucestershire Hospitals NHS Foundation Trust /ID# 241189, Cheltenham, Gloucestershire, United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
