Trial · NCT04041050
A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
NCT04041050, Phase 1, Active not recruiting, AbbVie
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm. Trials, record NCT04041050. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04041050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
- NCT number
- NCT04041050
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 85 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Myeloproliferative Neoplasm
- Interventions
- Navitoclax, Ruxolitinib, Celecoxib
- First posted
- 2019-08-01
- Last updated
- 2025-02-14
- Other registries' IDs
- eudract:2020-002597-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Dose Limiting Toxicities (DLT) (Part 1 and Part 2) | Up to 28 days after the navitoclax initiation | Dose limiting toxicities for dose escalation purposes will be determined on events that occur during the first 28-day cycle of navitoclax. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Navitoclax (Part 2 and 5) | Up to approximately 1 day | Maximum Observed Plasma Concentration (Cmax) of Navitoclax. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Celecoxib (Part 4) | Up to approximately 1 day | Maximum Observed Plasma Concentration (Cmax) of Celecoxib. |
| Primary | Time to Cmax (peak time, Tmax) of Navitoclax (Part 2 and 5) | Up to approximately 1 day | Tmax defined as time to maximum observed plasma concentration of Navitoclax. |
| Primary | Time to Cmax (peak time, Tmax) of Celecoxib (Part 4) | Up to approximately 1 day | Tmax defined as time to maximum observed plasma concentration of Celecoxib. |
| Primary | Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Navitoclax | Up to approximately 2 days | Area under the plasma concentration-time curve from time zero to the last measurable concentration of Navitoclax. |
| Primary | Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Celecoxib (Part 4) | Up to approximately 2 days | Area under the plasma concentration-time curve from time zero to the last measurable concentration of Celecoxib. |
| Primary | Number of Participants with Adverse Events | From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years). | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Change in QT interval corrected for heart rate interval by Fridericia's correction formula (QTcF) (Part 3) | From first dose of study drug until 30 days following last dose of study drug. | Change in QTcF (Part 3). |
| Secondary | Overall Response Rate | Up to approximately 96 weeks | ORR according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment/European Leukemia Net (IWG-MRT/ELN) criteria for participants with myelofibrosis, essential thrombocythemia, and polycythemia vera, and according to IWG criteria for participants with CMML. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04041050
GET https://conductscience.org/api/trials/v1/NCT04041050/registered