EUCTR2012-004239-21-DE进行中（未招募）1 期
A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis - PERSIST-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 322
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). Intermediate -1 or -2 or high-risk (Passamonti et al 2010) PMF, PPV-MF, or PET-MF (Tefferi and Vardiman 2008; Barosi et al 2008)
- •2). Palpable splenomegaly = 5 cm below lower costal margin (LCM) in midclavicular line by physical examination
- •3). Total Symptom Score (TSS) = 13 on the MPN-SAF TSS 2.0, not including the inactivity question
- •4). Eligible to receive a medically appropriate BAT therapy, taking into account all contraindications and precautions of available BAT therapy options
- •5). In the judgement of the investigator, patient is not a candidate for treatment with ruxolitinib due to medical reasons
- •6). Age = 18 years old
- •7). Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •8). Peripheral blast count < 10%
- •9). Absolute neutrophil count > 500/µL
- •10). Patients who are platelet or red blood cell transfusion-dependent are eligible
- •11). Adequate liver and renal function, defined by liver transaminases (AST/SGOT and ALT/SGPT) = 3 × ULN (AST/ALT = 5 × ULN if transaminase elevation is related to MF), total bilirubin = 1.5 x ULN (= 3 x ULN if due to Gilbert disease or low-grade hemolysis), and creatinine = 2.5 mg/dL
- •12). At least 6 months from prior splenic irradiation
- •13). At least 12 months from prior 32P therapy
- •14). At least 1 week since prior treatment (most recent dose) with a potent CYP3A4 inhibitor
- •15). At least 4 weeks since any experimental treatment for PMF, PPV-MF, or PET-MF
- •16). At least 2 weeks since any treatment for PMF, PPV-MF, or PET-MF
- •17). If fertile, willing to use effective birth control methods during the study. Women of childbearing potential must use highly effective methods (defined as those resulting in a failure rate of <1% per year when used consistently and correctly) for the duration of study treatment and for 12 months after last dose of study drug. The contraceptive methods that are considered highly effective are intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release). Males must use a condom for the duration of the study and for 90 days after the last dose of study treatment. When abstinence is used as a method of birth control, only true abstinence is acceptable, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, ovulation, symptothermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •18). Willing to undergo and able to tolerate frequent MRI or CT assessments on study
- •19). Able to understand and willing to complete symptom assessments using a patient reported outcomes instrument
- •20). Able to understand and willing to sign the Informed Consent Form
- •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 178
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1). Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication
- •2). Life expectancy < 6 months
- •3). Prior treatment with a JAK2 inhibitor
- •4). Completed allogeneic stem cell transplantation (ASCT) or eligible for and willing to complete ASCT
- •5). History of splenectomy or planning to undergo splenectomy
- •6). Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situation that the treating physician judges would limit compliance with study requirements
- •7). Other malignancy within last 3 years other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
- •8). Inflammatory or chronic functional bowel disorder such as Crohn disease, inflammatory bowel disease, chronic diarrhea, or constipation
- •9). Clinically symptomatic and uncontrolled cardiovascular disease
- •10). History of any of the following, within 6 months prior to randomization: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure
- •11). New York Heart Association Class II, III, or IV congestive heart failure
- •12). Patients with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4) grade 2 cardiac arrhythmias may be considered for inclusion, with the approval of the medical monitor, if the arrhythmias are stable, asymptomatic and unlikely to affect patient safety. Patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade =3, corrected QT interval (QTc) prolongation > 450 ms or other factors that increase the risk for QT prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 mEq/L that is persistant and refractory to correction], or family history of long QT interval syndrome)
- •13). Erythropoietic agent within 28 days prior to randomization
- •14). Thrombopoietic agent within 14 days prior to randomization
- •15). Known seropositivity for human immunodeficiency virus (HIV)
- •16). Known active hepatitis A, B, or C virus infection
- •17). Women who are pregnant or lactating
研究者
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