A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
Public ClinicalTrials.gov record NCT04041050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04041050
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2019
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Feb 13, 2025
2019 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope /ID# 239769 | Duarte | California | 91010 | — |
| Providence - St. Jude Medical Center /ID# 242558 | Fullerton | California | 92835 | — |
| Moores Cancer Center at UC San Diego /ID# 229584 | La Jolla | California | 92093 | — |
| UCLA /Id# 222784 | Los Angeles | California | 90095-1678 | — |
| Northwestern University Feinberg School of Medicine /ID# 224203 | Chicago | Illinois | 60611-2927 | — |
| Norton Cancer Institute - St. Matthews /ID# 239300 | Louisville | Kentucky | 40207 | — |
| Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686 | Detroit | Michigan | 48202-2610 | — |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554 | Omaha | Nebraska | 68130 | — |
| Duplicate_East Carolina University Brody School of Medicine /ID# 238560 | Greenville | North Carolina | 27834 | — |
| Gabrail Cancer Center Research /ID# 228924 | Canton | Ohio | 44718 | — |
| Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550 | Gettysburg | Pennsylvania | 17325 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 228169 | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04041050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 13, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04041050 live on ClinicalTrials.gov.