Post- Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Primary Myelofibrosis
Conditions
Brief summary
This was an open-label, randomized, dose-finding study in patients with primary or secondary MF (Dynamic International Prognostic Scoring System \[DIPSS\] risk score of Intermediate-1 to High-Risk) who were previously treated with ruxolitinib. The study was designed to support a pacritinib dosage selection decision with evaluation of 3 dosages.
Interventions
DRUGPacritinib
Pacritinib
Sponsors
CTI BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008) 2. DIPSS Intermediate-1, Intermediate -2, or High-risk (Passamonti et al 2010) 3. Prior ruxolitinib treatment with failure to benefit or intolerance as defined by at least one of the following: 1. Treatment for ≥3 months with inadequate efficacy response defined as \<10% SVR by MRI or \<30% decrease from baseline in spleen length by physical examination or regrowth to these parameters following an initial response; and/or 2. Treatment for ≥28 days complicated by either i. Development of a red blood cell (RBC) transfusion requirement (at least 2 units/month for 2 months) ii. National Cancer Institute (NCI) CTCAE grade ≥3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of \<20 mg BID 4. Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination 5. TSS of ≥10 on the MPN-SAF TSS 2.0 or patients with a single symptom score of ≥5 or 2 symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats 6. Age ≥18 years old 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 8. Peripheral blast count of \<10% throughout the Screening period 9. Absolute neutrophil count of \>500/μL 10. Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase \[AST\]/serum glutamic-oxaloacetic transaminase \[SGOT\] and alanine aminotransferase \[ALT\]/serum glutamic-pyruvic transaminase \[SGPT\]), ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN, if transaminase elevation is related to MF), direct bilirubin ≤4× ULN, and creatinine ≤2.5 mg/dL 11. Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ≤1.5 × ULN 12. Left ventricular cardiac ejection fraction of ≥45% by echocardiogram or multigated acquisition (MUGA) scan 13. If fertile, willing to use effective birth control methods during the study 14. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study 15. Able to understand and willing to complete symptom assessments using a PRO instrument 16. Provision of informed consent
Exclusion criteria
1. Life expectancy \<6 months 2. Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete allo-SCT 3. History of splenectomy or planning to undergo splenectomy 4. Splenic irradiation within the last 6 months 5. Previously treated with pacritinib 6. Patients receiving high-dose ruxolitinib (more than 10 mg BID or 20 mg QD) who cannot tolerate tapering down ruxolitinib to 10 mg BID or less prior to the first dose of pacritinib 7. Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of ≤100 mg per day, within the last 2 weeks 8. Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks 9. Treatment with medications that can prolong the QTc interval within the last 2 weeks 10. Treatment with an experimental therapy within the last 28 days 11. Significant recent bleeding history defined as NCI CTCAE grade ≥2 within the last 3 months, unless precipitated by an inciting event (eg, surgery, trauma, or injury) 12. Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety. 13. New York Heart Association Class II, III, or IV congestive heart failure 14. Any history of CTCAE grade ≥2 cardiac dysrhythmias within the last 6 months. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the medical monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety. 15. QTc prolongation \>450 ms based on the mean of triplicate ECGs or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia \[defined as serum potassium \<3.0 mEq/L that is persistent and refractory to correction\], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval) 16. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication 17. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or constipation 18. Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma 19. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection or psychiatric illness or social situation that, in the judgment of the treating physician, would limit compliance with study requirements 20. Known seropositivity for human immunodeficiency virus 21. Known active hepatitis A, B, or C virus infection 22. Women who are pregnant or lactating 23. Concurrent enrollment in another interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Percent Change in Spleen Volume | From Baseline to Weeks 12 and 24 | Percent change from baseline |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spleen Length Reduction | From Baseline to Weeks 24 | Rate of reduction in spleen length from baseline |
| Frequency of RBC's or Platelet Transfusions | At week 24 | Number of patients |
| 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 |
| Number of Participants With Adverse Events | Randomization through 30 days post End-of-Treatment visit | — |
Countries
France, Hungary, Italy, South Korea, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pacritinib 100 mg QD Pacritinib: Pacritinib | 52 |
| Pacritinib 100 mg BID Pacritinib: Pacritinib | 55 |
| Pacritinib 200 mg BID Pacritinib: Pacritinib | 54 |
| Total | 161 |
Baseline characteristics
| Characteristic | Total | Pacritinib 100 mg QD | Pacritinib 100 mg BID | Pacritinib 200 mg BID |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 118 Participants | 36 Participants | 44 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 16 Participants | 11 Participants | 16 Participants |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 8.14 | 69 years STANDARD_DEVIATION 8.8 | 68.9 years STANDARD_DEVIATION 6.9 | 68.1 years STANDARD_DEVIATION 8.76 |
| BMI | 26.3 kg/m^2 STANDARD_DEVIATION 4.4 | 25.1 kg/m^2 STANDARD_DEVIATION 3.79 | 27.2 kg/m^2 STANDARD_DEVIATION 4.11 | 26.4 kg/m^2 STANDARD_DEVIATION 5 |
| ECOG PS 0 | 42 participants | 11 participants | 14 participants | 17 participants |
| ECOG PS 1 | 90 participants | 32 participants | 29 participants | 29 participants |
| ECOG PS 2 | 29 participants | 9 participants | 12 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 5 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) White | 139 Participants | 44 Participants | 47 Participants | 48 Participants |
| Sex: Female, Male Female | 69 Participants | 21 Participants | 26 Participants | 22 Participants |
| Sex: Female, Male Male | 92 Participants | 31 Participants | 29 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 52 | 4 / 55 | 5 / 54 |
| other Total, other adverse events | 24 / 52 | 34 / 55 | 36 / 54 |
| serious Total, serious adverse events | 19 / 52 | 20 / 55 | 25 / 54 |
Outcome results
Primary
Patient Global Impression Assessment
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.
Time frame: From Baseline to Weeks 12 and 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 24 -Any Worse | 5 Participants |
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 12 - Any Improved | 17 Participants |
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 12 -Any Worse | 8 Participants |
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 24 - Any Improved | 10 Participants |
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 12 -No Change | 6 Participants |
| Pacritinib 100 mg QD | Patient Global Impression Assessment | Week 24 -No Change | 6 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 12 - Any Improved | 21 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 24 -No Change | 5 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 12 -Any Worse | 8 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 24 -Any Worse | 3 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 12 -No Change | 5 Participants |
| Pacritinib 100 mg BID | Patient Global Impression Assessment | Week 24 - Any Improved | 13 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 24 -Any Worse | 2 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 12 - Any Improved | 23 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 12 -No Change | 8 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 24 - Any Improved | 18 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 24 -No Change | 1 Participants |
| Pacritinib 200 mg BID | Patient Global Impression Assessment | Week 12 -Any Worse | 3 Participants |
Primary
Percent Change in Spleen Volume
Percent change from baseline
Time frame: From Baseline to Weeks 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pacritinib 100 mg QD | Percent Change in Spleen Volume | Week 12 | 3.19 percent change from baseline | Standard Deviation 22.613 |
| Pacritinib 100 mg QD | Percent Change in Spleen Volume | Week 24 | -2.43 percent change from baseline | Standard Deviation 17.608 |
| Pacritinib 100 mg BID | Percent Change in Spleen Volume | Week 12 | 6.37 percent change from baseline | Standard Deviation 31.11 |
| Pacritinib 100 mg BID | Percent Change in Spleen Volume | Week 24 | 0.65 percent change from baseline | Standard Deviation 20.589 |
| Pacritinib 200 mg BID | Percent Change in Spleen Volume | Week 12 | -3.60 percent change from baseline | Standard Deviation 26.61 |
| Pacritinib 200 mg BID | Percent Change in Spleen Volume | Week 24 | -11.30 percent change from baseline | Standard Deviation 26.417 |
Primary
Spleen Volume Reduction Response (≥ 35%)
Number of patients achieving a ≥ 35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans
Time frame: From Baseline to Weeks 12 and 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pacritinib 100 mg QD | Spleen Volume Reduction Response (≥ 35%) | End of Week 12 | 0 Participants |
| Pacritinib 100 mg QD | Spleen Volume Reduction Response (≥ 35%) | End of Week 24 | 0 Participants |
| Pacritinib 100 mg BID | Spleen Volume Reduction Response (≥ 35%) | End of Week 12 | 2 Participants |
| Pacritinib 100 mg BID | Spleen Volume Reduction Response (≥ 35%) | End of Week 24 | 1 Participants |
| Pacritinib 200 mg BID | Spleen Volume Reduction Response (≥ 35%) | End of Week 12 | 2 Participants |
| Pacritinib 200 mg BID | Spleen Volume Reduction Response (≥ 35%) | End of Week 24 | 5 Participants |
Primary
Total Symptom Score Analysis
Proportion of patients with ≥ 50% reduction in Total Symptom Score from baseline as assessed by the validated PRO instrument MPN-SAF TSS 2.0
Time frame: From Baseline to Weeks 12 and 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pacritinib 100 mg QD | Total Symptom Score Analysis | End of Week 12 | 1 Participants |
| Pacritinib 100 mg QD | Total Symptom Score Analysis | End of Week 24 | 2 Participants |
| Pacritinib 100 mg BID | Total Symptom Score Analysis | End of Week 24 | 0 Participants |
| Pacritinib 100 mg BID | Total Symptom Score Analysis | End of Week 12 | 1 Participants |
| Pacritinib 200 mg BID | Total Symptom Score Analysis | End of Week 24 | 2 Participants |
| Pacritinib 200 mg BID | Total Symptom Score Analysis | End of Week 12 | 2 Participants |
Secondary
Eastern Cooperative Oncology Group Performance Status
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
Time frame: At weeks 4, 12, 24, and 30 days post End-of-Treatment visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 4 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 3 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 1 | 20 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 1 | 28 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 2 | 4 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 2 | 8 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 3 | 1 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 1 | 12 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 3 | 1 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 0 | 10 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 4 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 2 | 5 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 5 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 2 | 9 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 5 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 1 | 19 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 3 | 2 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 0 | 10 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 0 | 11 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 4 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 5 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 4 - 5 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 24 - 4 | 0 Participants |
| Pacritinib 100 mg QD | Eastern Cooperative Oncology Group Performance Status | Week 12 - 0 | 11 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 2 | 10 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 5 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 3 | 1 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 5 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 0 | 11 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 1 | 27 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 2 | 16 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 3 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 4 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 0 | 9 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 1 | 23 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 2 | 10 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 4 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 5 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 0 | 6 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 1 | 15 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 2 | 5 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 3 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 4 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 5 | 0 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 0 | 8 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 1 | 23 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 3 | 1 Participants |
| Pacritinib 100 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 4 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 4 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 3 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 5 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 3 | 2 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 4 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 4 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 2 | 6 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 3 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 5 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 0 | 8 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 2 | 8 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 4 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 1 | 22 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 1 | 31 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 5 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 3 | 2 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 4 - 0 | 13 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 0 | 10 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 2 | 8 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | End of Treatment - 2 | 11 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 1 | 12 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 1 | 19 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 24 - 5 | 0 Participants |
| Pacritinib 200 mg BID | Eastern Cooperative Oncology Group Performance Status | Week 12 - 0 | 14 Participants |
Secondary
Frequency of RBC's or Platelet Transfusions
Number of patients
Time frame: At week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pacritinib 100 mg QD | Frequency of RBC's or Platelet Transfusions | 2.27 transfusions/month | Standard Deviation 2.987 |
| Pacritinib 100 mg BID | Frequency of RBC's or Platelet Transfusions | 1.18 transfusions/month | Standard Deviation 2.553 |
| Pacritinib 200 mg BID | Frequency of RBC's or Platelet Transfusions | 2.25 transfusions/month | Standard Deviation 2.345 |
Secondary
Number of Participants With Adverse Events
Time frame: Randomization through 30 days post End-of-Treatment visit
Population: Patients with ≥ 1 TEAE
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pacritinib 100 mg QD | Number of Participants With Adverse Events | 49 Participants |
| Pacritinib 100 mg BID | Number of Participants With Adverse Events | 51 Participants |
| Pacritinib 200 mg BID | Number of Participants With Adverse Events | 54 Participants |
Secondary
Spleen Length Reduction
Rate of reduction in spleen length from baseline
Time frame: From Baseline to Weeks 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pacritinib 100 mg QD | Spleen Length Reduction | 12.42 cm | Standard Deviation 5.602 |
| Pacritinib 100 mg BID | Spleen Length Reduction | 11.48 cm | Standard Deviation 6.501 |
| Pacritinib 200 mg BID | Spleen Length Reduction | 11.63 cm | Standard Deviation 7.131 |