EUCTR2020-005642-42-BG进行中（未招募）1 期
An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus-associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
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. Adults =18 years of age able to provide informed consent
- •2. Confirmed diagnosis of PMF, post–PV-MF, or post–ET-MF, as assessed by treating
- •physician according to the World Health Organization (WHO) criteria.
- •3. Palpable spleen measuring =5 cm below the left lower costal margin or spleen volume of =450 cm3 by magnetic resonance imaging (MRI) or computed tomography (CT) scan assessment.
- •4. Two symptoms with a score of at least 3 for each symptom, according to Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
- •5. High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS).
- •6. ECOG performance status of 0 to 1.
- •7. Adequate hematological, hepatic, and renal organ function (as per protocol definition and within 28 days prior to the first dose of study treatment).
- •8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use a highly effective contraception method during the study. In addition, male subjects must continue to use contraception for 3 months and 1 week after the last dose of study drug and female subjects must continue to use contraception for 1 month and 1 week after the last dose of study drug. A woman is considered of childbearing potential (ie fertile, following menarche and until becoming post-menopausal) unless permanently sterile.
- •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 54
排除标准
- •1. Arm 1 (KRT-232)
- •a. Subjects who are positive for p53 mutations.
- •b. Prior MDM2 inhibitor therapy or p53-directed therapy.
- •2. Arms 2,3 and 4(TL-895)
- •a. Prior treatment with any BTK, BMX inhibitor.
- •b. Require treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study provided the proton pump inhibitor is discontinued at least 3 days prior to first dose of study treatment.
- •c. Require receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of the first dose of study treatment.
- •3. Prior treatment with any JAK inhibitor.
- •4. Major surgery or planned major surgery within 28 days prior to the first dose of study treatment.
- •5. Chemotherapy, immunomodulating therapy, biologic therapy, or radiation therapy within 14 days prior to the first dose of study treatment. Hydroxyurea must be discontinued at least 14 days prior to the first dose of study treatment.
- •6. Participation in another interventional clinical trial within the past 4 weeks of the first dose of study treatment (participation in observational studies is permitted).
- •7. Prior splenectomy.
- •8. Splenic irradiation within 24 weeks prior to the first dose of study treatment.
- •9. Prior allogeneic stem-cell transplantation or eligible for allogeneic stem cell transplantation. Subjects who are eligible for hematopoietic stem cell transplantation per the opinion of the investigator, but who refuse transplant, are eligible for the study.
- •10. Women who are pregnant or breastfeeding.
- •11. History of major organ transplant.
- •12. Uncontrolled intercurrent illness including, but not limited to clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; unstable angina pectoris; unstable ventricular arrhythmia; or psychiatric illness/ social situations that would limit compliance with study requirements.
- •13. Subjects with known active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •14. Subjects with known history of HIV.
- •15. Subjects with clinically significant bacterial, mycobacterial, fungal, parasitic, or viral infection, including but not limited to hepatitis A, herpes zoster, and progressive multifocal leukoencephalopathy (PML). Subjects must have completed IV antibiotics at least 2 weeks prior to the first dose of study treatment.
- •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 normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma.
- •17. Grade 2 or higher QTc prolongation (>480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [NCI-CTCAE] criteria, version 5.0).
- •18. Major hemorrhage or intracranial hemorrhage within 24 weeks prior to the first dose of study treatment.
- •19. Having history of difficulty swallowing, gastric or small bowel surgery with history of malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study treatment.
- •20. Known hypersensitivity to or contraindications to the study drug, any of its excipients, or to required
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