EUCTR2020-003809-60-PL进行中（未招募）1 期
A phase 2, randomized, open-label, multicenter study to evaluate safety and efficacy of single agent selinexor versus treatment of physician’s choice in patients with previously treated myelofibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •Main Inclusion Criteria
- •1. A diagnosis of primary MF or post-ET or post-PV MF according to the 2016 WHO classification of MPN (Protocol Appendix 2), confirmed by the most recent local pathology report.
- •2. Previous treatment with JAK inhibitors for at least 6 months.
- •3. Measurable splenomegaly during the screening period as demonstrated by spleen volume of =450 cm3 by MRI or CT scan
- •4. Relapsed, refractory or intolerant to JAK inhibitors as defined as meeting one of the criteria below:
- •a. <35% spleen volume reduction by MRI or CT-scan (from baseline) or
- •b. <50% decrease in spleen size by palpation (from baseline) or an increase of at least 3 cm with the spleen at least 5 cm below the left costal margin or
- •c. Spleen volume increase >25% from nadir or a return to within 10% of baseline after any initial response or
- •d. Treatment with JAK inhibitor was complicated by development of RBC transfusion requirement (2 units per month for 2 month); or grade 3 thrombocytopenia, anemia, hematoma/hemorrhage; or Grade 2 non- hematologic toxicity while on JAK inhibitors
- •5. Patients =18 years of age
- •6. ECOG =2
- •7. Platelet count =75 × 10^9/L
- •8. Absolute neutrophil count (ANC) =1.5 × 109/L
- •9. Serum direct bilirubin =1.5 × ULN; AST and ALT = 2.5 × ULN
- •10. Calculated creatinine clearance (CrCl) >15 mL/min based on the Cockcroft and Gault formula.
- •11. Patients with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/mL.
- •12. Patients with untreated hepatitis C virus (HCV) are eligible if there is a documentation of negative viral load per institutional standard.
- •13. Patients with history of human immunodeficiency virus (HIV) are eligible if they have CD4+ T-cell counts =350 cells/µL, negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- •14. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Childbearing potential excludes: Age >50 years and naturally
- •amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy.
- •15. Male patients who are sexually active must use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Male patients must agree not to donate sperm during the study treatment period.
- •16. Patients must sign written informed consent in accordance with federal, local and institutional guidelines.
- •Crossover from physician’s choice (PC) arm to selinexor (S) arm will be allowed for patients who develop progressive disease (>25% increase from nadir) or for those with <35% reduction at the Week 36 MRI assessment.
- •Patients should meet all inclusion and exclusion criteria prior to crossover.
- •Patients who crossover due to PD (>25% increase from nadir) confirmed by IRC or due to <35% reduction in spleen size at Week 36 MRI assessment confirmed by IRC, should have a wash-out of 10
排除标准
- •Patients are excluded from the study if any of the following criteria apply:
- •1. >5% blasts in peripheral blood or >10% blasts in bone marrow (i.e., accelerated phase).
- •2. Previous treatment with selinexor or other XPO1 inhibitors.
- •3. Use of any standard or experimental anti-MF therapy <21 days prior to Cycle 1 Day 1 (hydroxyurea or growth factors are allowed).
- •4. Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (Example: vomiting, or diarrhea that is CTCAE grade >1).
- •5. Received strong cytochrome P450 3A (CYP3A) inhibitors =7 days prior to selinexor dosing OR strong CYP3A inducers =14 days prior to selinexor dosing (Protocol Appendix 3).
- •6. Major surgery <28 days prior to C1D1.
- •7. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics,
- •antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- •8. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, prevent the patient from giving informed consent, or being compliant with the study procedures.
- •9. Female patients who are pregnant or lactating.
- •10. Patients with contraindications to use of selinexor or all the drugsintended to be used in the comparative treatment arm.
研究者
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