EUCTR2017-001772-28-ES进行中（未招募）1 期
An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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. DIPSS Intermediate-1, Intermediate -2, or High risk (Passamonti et al 2010)
- •3. Prior ruxolitinib treatment failure or intolerance as defined by:
- •a. Treatment for =6 months with inadequate efficacy response (any measure) in the judgement of the investigator
- •b. Treatment for =28 days complicated by either:
- •i. RBC transfusion
- •ii. NCI CTCAE grade =3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of <20 mg BID
- •4. Palpable splenomegaly =5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
- •5. Platelet count of =100,000/µL at any time during the screening period and prior to first dose of pacritinib, including patients who are platelet transfusion-dependent
- •6. TSS of =10 on the MPN-SAF TSS 2.0
- •7. Age =18 years old
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •9. Peripheral blast count of <10%
- •10. Absolute neutrophil count of >500/µL
- •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), direct bilirubin =4× ULN, and creatinine =2.5 mg/dL
- •12. Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of =1.5 × ULN
- •13. Left ventricular cardiac ejection fraction of =45% by echocardiogram or multigated acquisition (MUGA) scan
- •14. QTc interval of <450 ms as assessed by ECG and corrected by the Fredericia method
- •15. If fertile, willing to use effective birth control methods during the study
- •16. Willing to undergo and able to tolerate frequent MRI or CT assessments during the study
- •17. Able to understand and willing to complete symptom assessments using a patient-reported outcomes instrument
- •18. 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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Life expectancy <6 months
- •2. Completed ASCT or are eligible for and willing to complete ASCT
- •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 anticoagulation or antiplatelet agents, except for aspirin dosages of =100 mg per day, within the last 2 weeks
- •7. Treatment with a potent cytochrome P450 (CYP450) inducer within the last 2 weeks
- •8. Treatment with medications that can prolong the QTc interval within the last 2 weeks
- •9. Significant recent bleeding history defined as NCI CTCAE grade =2 within the last 3 months, unless precipitated by an inciting event (e.g., surgery, trauma, injury)
- •10. Any history of CTCAE grade =2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
- •11. New York Heart Association Class II, III, or IV congestive heart failure
- •12. Any history of CTCAE grade =2 cardiac dysrhythmias within the last 6 months. 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.
- •13. QTc 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], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval)
- •14. Any gastrointestinal or metabolic condition that could interfere with absorption of oral medication
- •15. Inflammatory or chronic functional bowel disorder such as Crohn’s Disease, inflammatory bowel disease, chronic diarrhea, or constipation
- •16. Other malignancy within the 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
- •17. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection or psychiatric illness or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
- •18. Known seropositivity for human immunodeficiency virus
- •19. Known active hepatitis A, B, or C virus infection
- •20. Women who are pregnant or lactating
研究者
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