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:
- •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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