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ACTIVE NOT RECRUITING Phase 1

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

NCT04041050 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 85 participants
Start Date 2019-11-08
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04041050

The ClinicalTrials.gov registry entry for NCT04041050 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04041050 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Other, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04041050?

The interventions under investigation include: Celecoxib (DRUG), Ruxolitinib (DRUG), Navitoclax (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04041050?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial