EUCTR2017-001772-28-HU进行中（未招募）1 期
An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with 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
- 150
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
入选标准
- •1. PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008, Appendix 4)
- •2. DIPSS Intermediate-1, Intermediate -2, or High risk (Passamonti et al. 2010, Appendix 3)
- •3. Prior ruxolitinib treatment with failure to benefit or intolerance as defined by at least one of the following:
- •a. Treatment for =3 months with inadequate efficacy response defined as <10% spleen volume reduction by MRI or <30% decrease from baseline in spleen length by physical examination or regrowth to to these parameters following an initial response; and/or
- •b. Treatment for =28 days complicated by either:
- •i. Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months)
- •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. TSS of =10 on the MPN-SAF TSS 2.0 patients with a single symptom score of =5 or two symptoms =3 including only the symptoms of left upper quadrant pain, bone pain, itching or night sweats (Appendix 3)
- •6. Age =18 years old
- •7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Appendix 6)
- •8. Peripheral blast count of <10% throughout the screening period
- •9. Absolute neutrophil count of >500/µL
- •10. 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
- •11. Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of =1.5 × ULN
- •12. Left ventricular cardiac ejection fraction (LVEF) of =45% by echocardiogram or multigated acquisition (MUGA) scan
- •13. If fertile, willing to use effective birth control methods during the study
- •14. Willing to undergo and able to tolerate frequent MRI or CT assessments during the study
- •15. Able to understand and willing to complete symptom assessments using a patient-reported outcomes 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Life expectancy <6 months
- •2. Completed allo-SCT or are eligible for and willing to complete allo-SCT
- •3. History of splenectomy or planning to undergo splenectomy
- •4. Splenic irradiation within the last 6 months
- •5. Previously treated with pacritinib
- •6. Patients receiving high-dose ruxolitinib (more than 10 mg BID or 20
- •mg QD) who cannot tolerate tapering down ruxolitinib to 10 mg BID or
- •less prior to the first dose of pacritinib
- •7. Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of =100 mg per day, within the last 2 weeks
- •8. Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) inducer within the last 2 weeks
- •9. Treatment with medications that can prolong the QTc interval within the last 2 weeks
- •10. Treatment with an experimental therapy within the last 28 days
- •11. 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)
- •12. 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.
- •13. New York Heart Association Class II, III, or IV congestive heart failure
- •14. 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.
- •15. 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)
- •16. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
- •17. Active or uncontrolled Inflammatory or chronic functional bowel disorder such as Crohn’s Disease, inflammatory bowel disease, chronic diarrhea, or constipation
- •18. 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
- •19. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection or psychiatric illness or social situation that, in the judgment of the treatin
研究者
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