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PACIFICA Phase 3: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515953-52-00
Acronym
PAC303
Enrollment
207
Registered
2024-11-08
Start date
2020-07-24
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Essential Thrombocythaemia Myelofibrosis, Post-Polycythaemia Vera Myelofibrosis, Primary Myelofibrosis

Brief summary

1. Percentage of patients who achieve at least 35% reduction in spleen volume from baseline as measured by MRI (preferred) or CT scan at Week 24., 2. Percentage of patients with at least 50% reduction in TSS from baseline at Week 24 (as defined by the Myeloproliferative Neoplasm Symptom Assessment Form [MPN‐SAF TSS 2.0] excluding the “tiredness” component)

Detailed description

1. Percentage of patients who self-assess as “very much improved” or “much improved” at Week 24, 2. Time from randomization to the date of death due to any cause, 3. Incidence and severity of TEAEs, including SAEs and deaths, as well as laboratory values and vital signs, including cardiac evaluations from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy

Interventions

DRUGMETHYLPREDNISOLONE
DRUGPacritinib
DRUGDANAZOL
DRUGDEXAMETHASONE
DRUGPREDNISONE
DRUGRUXOLITINIB
DRUGPREDNISOLONE

Sponsors

Sobi Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Percentage of patients who achieve at least 35% reduction in spleen volume from baseline as measured by MRI (preferred) or CT scan at Week 24., 2. Percentage of patients with at least 50% reduction in TSS from baseline at Week 24 (as defined by the Myeloproliferative Neoplasm Symptom Assessment Form [MPN‐SAF TSS 2.0] excluding the “tiredness” component)

Secondary

MeasureTime frame
1. Percentage of patients who self-assess as “very much improved” or “much improved” at Week 24, 2. Time from randomization to the date of death due to any cause, 3. Incidence and severity of TEAEs, including SAEs and deaths, as well as laboratory values and vital signs, including cardiac evaluations from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy

Countries

Bulgaria, Czechia, France, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026