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NCT04041050 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
A Phase 1 study of Myeloproliferative Neoplasm, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT04041050: Active Phase 1 study of Myeloproliferative Neoplasm, sponsored by AbbVie.
NCT04041050 is a Phase 1 study of Myeloproliferative Neoplasm that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 85 participants, roughly in line with the 83-participant average among 40 other Myeloproliferative Neoplasm trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04041050, a Phase 1 study of Myeloproliferative Neoplasm, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Dose limiting toxicities for dose escalation purposes will be determined on events that occur during the first 28-day cycle of navitoclax.
Conditions Studied
Interventions
- DRUG Celecoxib
- DRUG Ruxolitinib
- DRUG Navitoclax
Study Locations (20)
California
- City of Hope /ID# 239769 - Duarte
- Providence - St. Jude Medical Center /ID# 242558 - Fullerton
- Moores Cancer Center at UC San Diego /ID# 229584 - La Jolla
- UCLA /Id# 222784 - Los Angeles
Other
- UMHAT Sveti Georgi /ID# 240022 - Plovdiv
- UMHAT Sveti Ivan Rilski /ID# 240077 - Sofia
- AP-HP - Hopital Saint-Louis /ID# 240685 - Paris
- IUCT Oncopole /ID# 242353 - Toulouse
Illinois
- Northwestern University Feinberg School of Medicine /ID# 224203 - Chicago
Kentucky
- Norton Cancer Institute - St. Matthews /ID# 239300 - Louisville
Michigan
- Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686 - Detroit
Nebraska
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554 - Omaha
North Carolina
- Duplicate_East Carolina University Brody School of Medicine /ID# 238560 - Greenville
Ohio
- Gabrail Cancer Center Research /ID# 228924 - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04041050 still lists
NCT04041050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, roughly in line with the 83-participant average among 40 other Myeloproliferative Neoplasm trials with a reported enrollment target.
The record links to 1 condition, with Myeloproliferative Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Celecoxib is the first listed.
NCT04041050 names 20 study sites across 14 states, led by California, Other, Illinois.
Frequently Asked Questions
What is clinical trial NCT04041050 about?
NCT04041050 is a clinical study titled "A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm". 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 dos...
What is the current status of trial NCT04041050?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2019-11-08. Estimated completion is 2026-12-31.
What conditions does trial NCT04041050 study?
This clinical trial studies the following conditions: Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT04041050?
The interventions under investigation include: Celecoxib (DRUG), Ruxolitinib (DRUG), Navitoclax (DRUG).
Who is sponsoring clinical trial NCT04041050?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04041050 being conducted?
This trial has 20 study locations across California, Illinois, Kentucky, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04041050's enrollment target sits among peer trials
85 14th of 40 higher than 27 of 40 other Myeloproliferative Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myeloproliferative Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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