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

CTI BioPharma Corp.0 个研究点目标入组 348 人开始时间: 2020年5月31日最近更新: 2020年11月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: CTI BioPharma Corp.
入组人数: 348

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) (based on two measurements taken on different days; both measurements must be <50,000/µL)
•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.If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one ofthe following criteria:
•a.Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days orless. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy andcontinues for 90 calendar days, regardless of whether therapy is administered continuously orintermittently during that interval.
•b.Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with aduration of 180 days or less. The 180-day period starts on the date of first ruxolitinibadministration and continues for 180 calendar days, regardless of whether therapy isadministered continuously or intermittently. The patient may not have received >10 mg ofruxolitinib on any day during that interval.
•The 90- or 180-day period may overlap with the Screening period but may not extend into the washout period (14 days prior to treatment Day 1).
•7.Age =18 years
•8.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•9.Peripheral blast count of <10% throughout the Screening period and prior to randomization
•10.Absolute neutrophil count of =500/µL
•11.Left ventricular cardiac ejection fraction of =50% by echocardiogram or multigated acquisition scan
•12.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), direct bilirubin =4 × ULN, andcreatinine =2.5 mg/dL
•13.Adequate coagulation defined by prothrombin time (PT)/international normalized ratio (INR) andPTT =1.5 × ULN
•14.If fertile, willing to use effective birth control methods during the study
•15.Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
•16.Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
•17.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 139
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 209

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. Treatment with an experimental therapy within 28 days prior to treatment Day 1
•9. Systemic treatment with a strong CYP3A4 inhibitor or a strong CYP450 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.
•10.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)
•11.Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of =100 mg per day), anti-vascular endothelial growth factor (anti-VEGF) agents, and daily use of COX-1 inhibiting Nonsteroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1
•12.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
•13.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.
•14.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
•15.QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome)
•16.New York Heart Association Class II, III, or IV congestive heart failure
•17.Any active GI or metabolic condition that could interfere with absorption of oral medication
•18.Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn’s disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
•19.Other malignancy within 3 years prior to treatment Day 1, other than curatively treated basal cell or squamous cell skin or corneal cancer; curatively treated carcinoma in situ of the cervix; organ-confined prostate cancer with prostate-specific antigen (PSA) <20 ng/mL and National Comprehensive Cancer Network risk of Very Low, Low, or Favorable Intermediate; curatively treated non-metastatic prostate cancer with negative PSA; or in situ breast carcinoma after complete surgical resection
•20.Uncontrolled intercurrent illness, including, but not limited to, ongoing active

研究者

发起方

CTI BioPharma Corp.

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