EUCTR2017-001772-28-IT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 - NA
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. Red blood cell transfusion
- •ii. National Cancer Institute (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 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 u pper l imit o f n ormal ( ULN) ( AST/ALT = 5 × U LN i f t ransaminase
- •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
- •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 allogeneic stem cell transplant (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
- •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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