PACIFICA Phase 3: 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 Counts <50,000/µL) - PACIFICA

Sobi Inc.0 个研究点目标入组 399 人开始时间: 2020年9月14日最近更新: 2024年7月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Sobi Inc.
入组人数: 399

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008)
•2.Platelet count of <50,000/µL at Screening (Day -35 to Day -3)
•3.DIPSS Intermediate-1, Intermediate-2, or High risk (Passamonti et al 2010)
•4.Palpable splenomegaly =5 cm below the lower costal margin (LCM) in the midclavicular line asassessed by physical examination
•5.TSS of =10 on the MPN-SAF TSS 2.0 or a single symptom score of =5 or two symptoms of =3,including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats. The TSS criteria need only to be met on a single day.
•6.Age =18 years
•7.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•8.Peripheral blast count of <10% throughout the Screening period and prior to randomization
•9.Absolute neutrophil count of =500/µL
•10.Left ventricular cardiac ejection fraction of =50% by echocardiogram or multigated acquisition scan
•11.Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase[AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase[ALT]/serum glutamic pyruvic transaminase [SGPT]) =3 × the upper limit of normal (ULN)(AST/ALT =5 × ULN if transaminase elevation is related to MF), total bilirubin .4 ? ULN (in cases where total bilirubin is elevated, direct bilirubin =4 × ULN is required), andcreatinine =2.5 mg/dL
•12.Adequate coagulation defined by prothrombin time (PT)/international normalized ratio (INR) andPTT =1.5 × ULN
•13.If fertile, willing to use highly effective birth control methods during the study (see Section 7.1.2.5 for acceptable birth control methods).
•14.Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
•15.Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
•16.Provision of informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 169
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 230

排除标准

•1. Life expectancy <6 months
•2. Completed allogeneic SCT, or are eligible for and willing to complete other approved available therapy including allogeneic SCT
•3. History of splenectomy or planning to undergo splenectomy
•4. Splenic irradiation within the last 6 months
•5. Previously treated with pacritinib
•6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
•7. Prior treatment with more than one JAK2 inhibitor
•8. Prior treatment with ruxolitinib, if BOTH of 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 days, from first to last exposure (i.e., this 90-day period starts on the date of first administration of ruxolitinib at a total daily dose of >10 mg and continues for 90 calendar days, regardless of whether higher-dose ruxolitinib is administered continuously or intermittently).
•9. Prior treatment with any JAK2 inhibitor other than ruxolitinib, irrespective of dose, with a duration of >90 days. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently.
•10. Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1
•11. Systemic treatment with a strong P450 3A4 (CYP3A4) inhibitor or a strong CYP3A4 inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1.
•12.Significant recent bleeding history defined as NCI CTCAE grade =2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)
•13.Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of =100 mg per day) and daily use of COX-1 inhibiting Nonsteroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1. Treatment with systemic anti-vascular endothelial growth factor (anti-VEGF) agents within 28 days prior to treatment Day 1.
•14.Systemic treatment with medications that can prolong the QT interval within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
•15.Any history of CTCAE grade =2 non-dysrhythmia cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Medical Monitor, if stable and unlikely to affect patient safety.
•16.Any history of CTCAE grade =2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the Medical Monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety
•17.QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction

研究者

发起方

Sobi Inc.

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