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RecruitingLast updated:31 May 2022

PACIFICA: This phase III trial is comparing the effectiveness of targeted therapy (pacritinib) with the physician's choice of treatment (either corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib) in people with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia MyelofibrosisA 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 Count <50,000>

Clinical summary

Summary

This is a randomised, controlled trial for people with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis, who have had no or limited exposure to any JAK2 inhibitor, or are JAK2 inhibitor-naive, and who have severe thrombocytopenia. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food. In the Active Comparator Arm, participants will receive the physician's choice of therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization.

Age

People18+

Phase

III

Trial Acronym

PACIFICA

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Trial Identifiers

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Commercial Sponsor

CTI BioPharma

Scientific Title

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 Count <50,000>

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • You are able to swallow medication by mouth.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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