A Phase 2 study to evaluate the efficacy and safety of selinexor monotherapy in subjectswith JAK inhibitor-naïve myelofibrosis and moderate thrombocytopenia. - XPORT-MF-044

Karyopharm Therapeutics Inc.0 个研究点目标入组 58 人2024年2月20日

适应症moderate thrombocytopenia, JAK inhibitor-naïve myelofibrosis MedDRA version: 20.0Level: PTClassification code: 10043554Term: Thrombocytopenia Class: 100000004851 MedDRA version: 20.0Level: PTClassification code: 10028537Term: Myelofibrosis Class: 100000004864 Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: moderate thrombocytopenia, JAK inhibitor-naïve myelofibrosis
发起方: Karyopharm Therapeutics Inc.
入组人数: 58
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2024年2月20日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Karyopharm Therapeutics Inc.

入排标准

入选标准

•A diagnosis of MF or post\-ET or post\-PV MF according to the 2016 World Health Organization (WHO) classification of MPN in Appendix 2 (Arber 2016\), confirmed by the most recent local pathology report., Subjects with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for \>8 weeks and the viral load is \<100 IU/mL., Subjects with history of hepatitis C virus (HCV) are eligible if they have received adequate curative anti\-HCV treatment and HCV viral load is below the limit of quantification., Subjects with history of human immunodeficiency virus (HIV) are eligible if they have cluster of differentiation 4 (CD4\) \+ T\-cell counts \=350 cells/µL, negative viral load, and no history of acquired immunodeficiency syndrome (AIDS)\-defining opportunistic infections in the last year and should be on established antiretroviral therapy (ART) for at least 4 weeks., Female subjects of childbearing potential must have a negative serum pregnancy test at screening and within 3 days prior to first dose on C1D1 and agree to use highly effective methods of contraception throughout the selinexor treatment period and for 90 days following the last dose of selinexor treatment. A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming post\-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause., Male subjects who are sexually active must use a barrier method in addition to highly effective methods of contraception throughout the study treatment period and for 90 days following the last dose of selinexor treatment. Male subjects must agree not to donate sperm during the study treatment period and for at least 90 days after the last dose of selinexor treatment., Subjects must sign written informed consent in accordance with federal, local, and institutional guidelines., Active symptoms of MF as determined by presence of at least 2 symptoms with a score \=3 or total score of \=10 at screening using the MFSAF V4\.0\., Subjects must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study., Life expectancy of greater than 6 months in the opinion of the Investigator., Subjects with no other concomitant malignancies or history of another malignancy within 2 years prior to C1D1 except for adequately treated early\-stage basal cell or squamous cell carcinoma of skin, adequately treated carcinoma in situ of breast or cervix or organ confined prostate cancer, or PV or ET., Measurable splenomegaly during the screening period as demonstrated by spleen volume of \=450 cm3 by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to screening are acceptable)., Subject is currently not a candidate for stem cell transplantation., Subjects must be willing to complete the MFSAF) V4\.0 daily during the study for evaluating the symptom response (i.e., TSS50\)., Subjects must be able to voluntarily provide written informed consent per all relevant rules and institutional policies before any study procedures are performed. In instances where subjects cannot provide written informed consent, an authorized representative may be utilized as permitted by local law., Subjects with DIPSS risk category of intermediate\-1 with symptoms, o

排除标准

•More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)., Unable or unwilling to undergo CT scan or MRI per protocol., Subjects with contraindications or known hypersensitivity to selinexor or excipients., History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack \[TIA]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class \>2 within 6 months of C1D1\., Subjects unable to tolerate two forms of antiemetics prior to each dose for the first two cycles., Previous treatment with JAK inhibitors for MF., Previous treatment with selinexor or other XPO1 inhibitors., Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting or diarrhea \> Common Terminology Criteria for Adverse Events \[CTCAE] v5\.0 Grade 2 or higher), Grade 3 or higher hyponatremia, Grade 3 or higher fatigue, or Grade 2 or higher ocular toxicity., Major surgery \<28 days prior to C1D1\., Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to C1D1; however, prophylactic use of these agents is acceptable (including parenteral)., Any life\-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the subject’s safety, prevent the subject from giving informed consent, or being compliant with the study procedures, or confound the ability to interpret study results., Female subjects who are pregnant or lactating., Prior splenectomy, or splenic radiation within 6 months prior to C1D1\.