Trial · NCT04884191
Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib
NCT04884191, Phase 2, Completed, CTI BioPharma; results first posted 2022-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib. Trials, record NCT04884191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04884191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib
- NCT number
- NCT04884191
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- CTI BioPharma
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post- Essential Thrombocythemia Myelofibrosis
- Interventions
- Pacritinib
- First posted
- 2021-05-12
- Last updated
- 2022-06-01
- Results first posted
- 2022-06-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spleen Volume Reduction Response (≥ 35%) | From Baseline to Weeks 12 and 24 | Number of patients achieving a ≥ 35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans |
| Primary | Percent Change in Spleen Volume | From Baseline to Weeks 12 and 24 | Percent change from baseline |
| Primary | Total Symptom Score Analysis | From Baseline to Weeks 12 and 24 | Proportion of patients with ≥ 50% reduction in Total Symptom Score from baseline as assessed by the validated PRO instrument MPN-SAF TSS 2.0 |
| Primary | Patient Global Impression Assessment | From Baseline to Weeks 12 and 24 | Number of patients with improvement in PGIA. The Patient Global Impression Assessment questionnaire was completed at the end of Week 12 and end of Week 24. The scores were summarized by treatment group at each visit. |
| Secondary | Spleen Length Reduction | From Baseline to Weeks 24 | Rate of reduction in spleen length from baseline |
| Secondary | Frequency of RBC's or Platelet Transfusions | At week 24 | Number of patients |
| Secondary | Eastern Cooperative Oncology Group Performance Status | At weeks 4, 12, 24, and 30 days post End-of-Treatment visit | 0 = Fully active, able to carry on all pre-disease performance without restriction 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. = Dead |
| Secondary | Number of Participants With Adverse Events | Randomization through 30 days post End-of-Treatment visit |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Spleen Volume Reduction Response (≥ 35%) | From Baseline to Weeks 12 and 24 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percent Change in Spleen Volume | From Baseline to Weeks 12 and 24 | The difference between the number of participants analyzed in Week 12 vs. Week 24 is the result of the number of participants that continued to complete the study. Participants that were not analyzed were withdrawn from the study for various reasons. | percent change from baseline | MEAN |
| PRIMARY | Total Symptom Score Analysis | From Baseline to Weeks 12 and 24 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Patient Global Impression Assessment | From Baseline to Weeks 12 and 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Spleen Length Reduction | From Baseline to Weeks 24 | cm | MEAN | |
| SECONDARY | Frequency of RBC's or Platelet Transfusions | At week 24 | transfusions/month | MEAN | |
| SECONDARY | Eastern Cooperative Oncology Group Performance Status | At weeks 4, 12, 24, and 30 days post End-of-Treatment visit | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Randomization through 30 days post End-of-Treatment visit | Patients with ≥ 1 TEAE | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 100 mg QD | End of Week 12 | 0 | Participants | |
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 100 mg BID | End of Week 12 | 2 | Participants | |
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 200 mg BID | End of Week 12 | 2 | Participants | |
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 100 mg QD | End of Week 24 | 0 | Participants | |
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 100 mg BID | End of Week 24 | 1 | Participants | |
| Spleen Volume Reduction Response (≥ 35%) | Pacritinib 200 mg BID | End of Week 24 | 5 | Participants | |
| Percent Change in Spleen Volume | Pacritinib 100 mg QD | Week 12 | 3.19 | Standard Deviation 22.613 | percent change from baseline |
| Percent Change in Spleen Volume | Pacritinib 100 mg BID | Week 12 | 6.37 | Standard Deviation 31.110 | percent change from baseline |
| Percent Change in Spleen Volume | Pacritinib 200 mg BID | Week 12 | -3.60 | Standard Deviation 26.610 | percent change from baseline |
| Percent Change in Spleen Volume | Pacritinib 100 mg QD | Week 24 | -2.43 | Standard Deviation 17.608 | percent change from baseline |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pacritinib 100 mg QD | 55 | |
| Overall Study | STARTED | Pacritinib 100 mg BID | 55 | |
| Overall Study | STARTED | Pacritinib 200 mg BID | 55 | |
| Overall Study | COMPLETED | Pacritinib 100 mg QD | 52 | |
| Overall Study | COMPLETED | Pacritinib 100 mg BID | 55 | |
| Overall Study | COMPLETED | Pacritinib 200 mg BID | 54 | |
| Overall Study | NOT COMPLETED | Pacritinib 100 mg QD | 3 | |
| Overall Study | NOT COMPLETED | Pacritinib 100 mg BID | 0 | |
| Overall Study | NOT COMPLETED | Pacritinib 200 mg BID | 1 |
Source ClinicalTrials.gov
Adverse events267
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Pacritinib 100 mg QD | 6 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | Pacritinib 100 mg BID | 8 | 55 | |
| other | Diarrhoea | Gastrointestinal disorders | Pacritinib 200 mg BID | 14 | 54 | |
| other | Nausea | Gastrointestinal disorders | Pacritinib 100 mg QD | 7 | 52 | |
| other | Nausea | Gastrointestinal disorders | Pacritinib 100 mg BID | 7 | 55 | |
| other | Nausea | Gastrointestinal disorders | Pacritinib 200 mg BID | 3 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pacritinib 100 mg QD | 3 | 52 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pacritinib 100 mg BID | 5 | 55 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pacritinib 200 mg BID | 9 | 54 | |
| other | Fatigue | General disorders | Pacritinib 100 mg QD | 1 | 52 |
1 to 10 of 267Source ClinicalTrials.gov
See all 267 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pacritinib 100 mg QD | 6 | 52 |
| Total, all-cause mortality | Pacritinib 100 mg BID | 4 | 55 |
| Total, all-cause mortality | Pacritinib 200 mg BID | 5 | 54 |
| Total, other adverse events | Pacritinib 100 mg QD | 24 | 52 |
| Total, other adverse events | Pacritinib 100 mg BID | 34 | 55 |
| Total, other adverse events | Pacritinib 200 mg BID | 36 | 54 |
| Total, serious adverse events | Pacritinib 100 mg QD | 19 | 52 |
| Total, serious adverse events | Pacritinib 100 mg BID | 20 | 55 |
| Total, serious adverse events | Pacritinib 200 mg BID | 25 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34551507 | DERIVED |
Source PubMed
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/NCT04884191
GET https://conductscience.org/api/trials/v1/NCT04884191/results?page=2