A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm (NCT04041050)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope /ID# 239769 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (42 Sites)
Showing the first 25 of 42 sites.
- City of Hope /ID# 239769 — Duarte, California
- Providence - St. Jude Medical Center /ID# 242558 — Fullerton, California
- Moores Cancer Center at UC San Diego /ID# 229584 — La Jolla, California
- UCLA /Id# 222784 — Los Angeles, California
- Northwestern University Feinberg School of Medicine /ID# 224203 — Chicago, Illinois
- Norton Cancer Institute - St. Matthews /ID# 239300 — Louisville, Kentucky
- Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686 — Detroit, Michigan
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554 — Omaha, Nebraska
- Duplicate_East Carolina University Brody School of Medicine /ID# 238560 — Greenville, North Carolina
- Gabrail Cancer Center Research /ID# 228924 — Canton, Ohio
- Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550 — Gettysburg, Pennsylvania
- Virginia Commonwealth University Medical Center Main Hospital /ID# 228169 — Richmond, Virginia
- Cliniques Universitaires UCL Saint-Luc /ID# 225314 — Woluwe-Saint-Lambert, Brussels Capital
- UMHAT Sveti Georgi /ID# 240022 — Plovdiv,
- UMHAT Sveti Ivan Rilski /ID# 240077 — Sofia,
- Klinicki bolnicki centar Zagreb /ID# 240140 — Zagreb, City of Zagreb
- Centre Antoine Lacassagne - Nice /ID# 242293 — Nice, Alpes-Maritimes
- CHU Amiens-Picardie Site Sud /ID# 240792 — Amiens, Somme
- AP-HP - Hopital Saint-Louis /ID# 240685 — Paris,
- IUCT Oncopole /ID# 242353 — Toulouse,
- Universitaetsklinikum Freiburg /ID# 222791 — Freiburg im Breisgau, Baden-Wurttemberg
- Klinikum Kassel /ID# 225440 — Kassel, Hesse
- Universitaetsmedizin Rostock /ID# 225436 — Rostock, Mecklenburg-Vorpommern
- Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 224835 — Berlin,
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 221408 — Rome, Lazio
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Myeloproliferative Neoplasm
- Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms — Buffalo, New York
- Evaluation of the Pathobiology of CALR-mutated MPN Cells — Charlotte, North Carolina
- An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms — Irvine, California
- Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms — Toronto, Ontario
Explore by condition: All Myeloproliferative Neoplasm clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.