Trial · NCT04480086
Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis
NCT04480086, Phase 1, Terminated, AbbVie
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis. Trials, record NCT04480086. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04480086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis
- NCT number
- NCT04480086
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Myelofibrosis (MF)
- Interventions
- Mivebresib, Navitoclax, Ruxolitinib
- First posted
- 2020-07-21
- Last updated
- 2023-08-29
- Other registries' IDs
- eudract:2020-001226-65
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Up To Approximately 1 year from start of study | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Secondary | Percentage of Participants who Achieve Spleen Volume Reduction of 35% or Greater (SVR35) | Up To Week 24 | Reduction in spleen volume is measured by magnetic resonance imaging (MRI). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Mivebresib | Up To Week 12 | Maximum observed plasma concentration (Cmax) of Mivebresib. |
| Secondary | Time to Cmax (Tmax) of Mivebresib | Up To Week 12 | The amount of time taken to reach Cmax. |
| Secondary | Area Under Concentration vs Time Curve (AUC) of Mivebresib | Up To Week 12 | AUC of Mivebresib will be calculated. |
| Secondary | Half-Life (t1/2) of Mivebresib | Up To Week 12 | Half-life of Mivebresib will be calculated. |
| Secondary | Accumulation Ratio of Mivebresib | Up To Week 12 | Pharmacokinetic parameters will include accumulation ratio of Mivebresib. |
| Secondary | Apparent Clearance (CL/F) of Mivebresib | Up To Week 12 | CL/F of Mivebresib will be calculated. |
| Secondary | Apparent Volume of Distribution (Vd/F) of Mivebresib | Up To Week 12 | Vd/F of mivebresib will be calculated. |
| Secondary | Percentage of Participants With >= 50% Reduction in Total Symptom Score (TSS) | Week 24 | TSS is assessed using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. MFSAF v4.0 measures the burden of myelofibrosis-related symptoms. The symptoms are assessed on a 11-point numeric rating scale (NRS) anchored from 0 (absent) to 10 (worst imaginable). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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/NCT04480086
GET https://conductscience.org/api/trials/v1/NCT04480086/registered