PACIFICA Trial Study Design & Eligibility Criteria

Study Design

Chart
  • a • Prior treatment with ruxolitinib at doses no more than 10 mg is permitted with any duration of treatment.
  • • Prior treatment with ruxolitinib is excluded if BOTH the following conditions are met:
    • i. exposure to higher-dose ruxolitinib (>10mg daily) within 120 days prior to treatment day 1 AND
    • ii. total duration of treatment with higher dose ruxolitinib (>10mg daily) was >90 calendar days
  • • Prior treatment with any JAK2 inhibitor other than ruxolitinib, with a duration of >90 days is exclusionary
  • bA 2-week washout will be required for MF directed therapy and at least 28 days for experimental MF therapies.
  • cPhysician’s Choice therapy includes low-dose ruxolitinib (no more than 10 mg/day), danazol, corticosteroids, or hydroxyurea per protocol specified country options.
    • BID=twice daily; DIPSS=Dynamic International Prognostic Scoring System; JAK=Janus kinase; MF=myelofibrosis; PET-MF=post-essential thrombocythemia MF; PGIC=patient global impression of change; PMF=primary MF; PPV-MF=post-polycythemia vera MF; SVR=spleen volume reduction; TSS=total symptom score.

Trial Eligibility Criteria

  • Key Inclusion Criteria
    • Adults with primary or secondary MF
    • Platelet count <50,000/μL
    • DIPSS Int-1/-2 or High Risk
    • Palpable spleen ≥5cm
    • TSS ≥10 on the MPN-SAF v2.0
    • ECOG performance status 0-2
    • LVEF ≥50%
    • Peripheral blasts <10%
    • Adequate hepatic and renal function, coagulation parameters and neutrophil count
  • Key Exclusion Criteria
    • Prior splenectomy or allogeneic HSCT
    • Any MF therapy within 14 days
    • Prior treatment with more than one JAK2 inhibitor*
    • Grade ≥2 bleeding within prior 3 months unless caused by an event
    • Medications that increase bleeding risk within 14 days
    • Grade ≥2 cardiac conditions within 6 months
    • QTc >450ms or medicines that prolong QT within 14 days
    • NYHA Class II-IV heart failure
    • Active bowel disorders
    • Non-MF malignancy within 3 years
    • *Patients with current or prior JAK2 inhibitor treatment are:
    • •Eligible if prior treatment with ruxolitinib was at doses no more than 10 mg (any duration of treatment is permitted).
    • •Excluded if BOTH the following conditions are met:
      • i. Exposure to higher-dose ruxolitinib (>10 mg daily) within 120 days prior to treatment day 1. AND
      • ii. Total duration of treatment with higher dose ruxolitinib (>10 mg daily) was >90 calendar days.
    • •Excluded if prior treatment with any JAK2 inhibitor other than ruxolitinib was >90 days.

For full eligibility criteria visit:

ClinicalTrials.gov
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