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NCT03165734 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
A Phase 3 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Swedish Orphan Biovitrum.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
- 20
- Study locations
NCT03165734: Recruiting Phase 3 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Swedish Orphan Biovitrum.
NCT03165734 is a Phase 3 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis that is actively recruiting participants, run by Swedish Orphan Biovitrum. The registered enrollment target is 399 participants, above the 108-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (269% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03165734, a Phase 3 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, is actively recruiting participants, sponsored by Swedish Orphan Biovitrum.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
Primary Outcome
To compare the efficacy of pacritinib with that of physician's choice (P/C) therapy, as assessed by the proportion of patients achieving a ≥35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans
Conditions Studied
Interventions
- DRUG Pacritinib
- DRUG Physician's Choice medications
Study Locations (20)
Maryland
- Saint Agnes Hospital - Baltimore
- Johns Hopkins University - Baltimore
- American Oncology Partners of Maryland, PA - Bethesda
- Regional Cancer Care Associates LLC - CCBD Division - Bethesda
California
- City of Hope - Duarte
- USC Norris Comprehensive Cancer Center - Los Angeles
- UCLA David Geffen School of Medicine - Los Angeles
Illinois
- Northwestern Memorial Hospital - Chicago
- Rush University Medical Center - Chicago
- The University of Chicago Medical Center - Chicago
Colorado
- University of Colorado Cancer Center - Aurora
- Rocky Mountain Cancer Centers (US Oncology/McKesson) - Boulder
District of Columbia
- Georgetown University Hospital - Washington D.C.
- George Washington University-Medical Faculty Associates - Washington D.C.
Alabama
- University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center - Birmingham
Arizona
- Mayo Clinic Hospital - Phoenix
Connecticut
- Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 3 |
What NCT03165734 shows while recruiting
NCT03165734 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (269% higher).
The record links to 3 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 2 interventions - of which Pacritinib is the first listed.
NCT03165734 names 20 study sites across 11 states, led by Maryland, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03165734 about?
NCT03165734 is a clinical study titled "A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis". This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 t...
What is the current status of trial NCT03165734?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2017-06-26. Estimated completion is 2027-07-30.
What conditions does trial NCT03165734 study?
This clinical trial studies the following conditions: Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis.
What interventions are being tested in trial NCT03165734?
The interventions under investigation include: Pacritinib (DRUG), Physician's Choice medications (DRUG).
Who is sponsoring clinical trial NCT03165734?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03165734 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03165734's enrollment target sits among peer trials
399 4th of 30 higher than 27 of 30 other Primary Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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