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Study Contact +4686972000
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Be Part of Research - Trial Details - A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
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A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Recruiting

Open to: ALL

Age: 18.0 - N/A

Oxford Gloucester Sheffield Glasgow London London London

Medical Conditions

Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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/ÎĽL). 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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2017 Dec 2026

Publications

"Gerds AT, Savona MR, Scott BL, Talpaz M, Egyed M, Harrison CN, Yacoub A, Vannucchi A, Mead AJ, Kiladjian JJ, O'Sullivan J, Garcia-Gutierrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Devineni S, Craig AR, Mascarenhas JO. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis. Blood Adv. 2020 Nov 24;4(22):5825-5835. doi: 10.1182/bloodadvances.2020003314."; "33232476"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base

Intervention Arm Group : Pacritinib 200 mg BID;

Intervention Type : DRUG
Intervention Description : Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.

Intervention Arm Group : Physician's Choice (P/C) therapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford University Hospitals NHS Trust - Churchill Hospital
    Oxford
  • Gloucestershire Royal Hospital
    Gloucester
  • Royal Hallamshire Hospital, Department of Hematology
    Sheffield
    South Yorkshire
  • Beatson West of Scotland Cancer Centre
    Glasgow
    G12 0ZD
  • Barts Health NHS Trust - The Royal London Hospital
    London
    E1 2ES
  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
    London
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital
    London

Study Contact +4686972000
medical.info@sobi.com



The study is sponsored by Swedish Orphan Biovitrum and is in collaboration with PSI CRO.



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Read full details for Trial ID: NCT03165734
Last updated 26 June 2025

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