PER-038-21尚未招募2 期
An Open-Label, Multicenter, Phase 2 Study Assessing the Safetyand Efficacy of KRT-232 or TL-895 in Janus-associated KinaseInhibitor Treatment-Naïve Myelofibrosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults =18 years of age.
- •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).
- •a. Hematologic:
- •ANC =1.0 × 109/L (Note: ANC eligibility is based on counts obtained in the absence of growth factors: ie, 7 days for G-CSF or 14 days for pegfilgrastim).
- •Platelet count =50 × 109/L.
- •b. Peripheral blood blast count <10%.
- •c. Hepatic:
- •Total bilirubin within normal limits (WNL); if total bilirubin is > upper limit of normal (ULN) then patients are eligible if the direct bilirubin is =2.0 x ULN.
- •Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT)
- •and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT)
- •=2.5 ULN.
- •d. Renal: estimated creatinine clearance =30 mL/min by Cockcroft Gault
- •8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use an 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. Effective birth control for males includes use of condoms. Effective birth control for females includes (a) combined estrogen- and progestogen- containing hormonal contraception (oral, intravaginal, transdermal); (b) intrauterine device combined with a barrier method; (c) intrauterine hormone-releasing system combined with a barrier method; (d) bilateral tubal occlusion/ligation; (e) vasectomized partner; (f) sexual abstinence, when this is in line with the preferred and usual lifestyle of the subject. Periodic abst
排除标准
- •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.
- •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.
- •Subjects who meet any of the following criteria will not be eligible for the study:
- •1. Arm 1 (KRT-232)
- •a. Subjects who are positive for p53 mutations.
- •b. Prior MDM2 inhibitor therapy or p53-directed therapy.
研究者
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