EUCTR2019-001201-24-IT进行中（未招募）1 期
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML) - KRT-232-104
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •2. ECOG performance status of 0 to 2
- •3. Part A: Patients with relapsed or refractory AML, or treatment naïve
- •AML secondary to MPN. Diagnosis of AML must be according to World
- •Health Organization (WHO) criteria with at least 20% blasts in the
- •marrow and/or extramedullary leukemia. Patients with known fms-like
- •tyrosine kinase 3 (FLT3) mutations must have been treated with a FLT3 inhibitor (unless contraindicated) if FLT3 inhibitors are approved and
- •available in the country in which the patient is to be treated. Patients
- •who are known isocitrate dehydrogenase 1 (IDH1) or IDH2 mutation
- •positive must have been previously treated with an IDH1 or IDH2
- •inhibitor, respectively, (unless contraindicated) if IDH1 or IDH2
- •inhibitors are approved and available in the country in which the patient
- •is to be treated.
- •4. Part B: Patients with AML secondary to MPN,as defined by =20%
- •blasts in the bone marrow or peripheral blood,or JAK2 mutation positive
- •5. Part B: Patients may have been treated with 0 to 2 prior lines of
- •therapy for their AML. Patients with known FLT3 mutations must have
- •been treated with a FLT3 inhibitor (unless contraindicated) if FLT3
- •inhibitors are approved and available in the country in which the patient
- •is to be treated. Patients with relapsed or refractory disease who are
- •known IDH1 or IDH2 mutation positive, must have been previously
- •treated with an IDH1 or IDH2 inhibitor (respectively) (unless
- •contraindicated) if IDH1 or IDH2 inhibitors are approved and available in
- •the country in which the patient is be treated.
- •6. Adequate hepatic and renal function within 28 days prior to the first
- •dose of KRT-232.
- •Hepatic: Direct bilirubin =2.0 times the upper limit of normal (ULN),
- •unless Gilbert's
- •Syndrome; aspartate transaminase/serum glutamic oxaloacetic
- •transaminase (AST/SGOT)
- •and alanine transaminase/serum glutamic pyruvic transaminase
- •(ALT/SGPT) =2.5 ULN. Renal: Estimated creatinine clearance =30
- •mL/min by Cockcroft Gault.
- •7. Females of childbearing potential and males who have partners of
- •childbearing potential must agree to use an effective contraception
- •method during the study. In addition, males must continue to use
- •contraception for 3 months and 1 week after the last dose of study drug
- •and females must continue to use contraception for 1 month and 1 week
- •after the last dose of study drug. Effective birth control includes (a)
- •combined, estrogen and progestogen containing, hormonal
- •contraception (oral, intravaginal, transdermal); (b) progestogen-only
- •hormonal contraception (oral, injectable, implantable); (c) intrauterine
- •device; (d) intrauterine hormone-releasing system; (e) bilateral tubal
- •occlusion; (f) vasectomized partner; and (g) sexual abstinence when this
- •is in line with the preferred and usual lifestyle of the subject. Periodic
- •abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •1. Patients who are TP53 mutation positive
- •2. Participants who are either refractory to or relapsed within 90 days of
- •receiving a regimen containing a cumulative dose of = 18 g/m2 of
- •cytarabine are not eligible to be treated with cytarabine on this study
- •but may be treated with decitabine on this study
- •3. Patients who have received prior treatment with decitabine are not
- •eligible to receive decitabine in this study but may be treated with
- •cytarabine on this study
- •4. Patients who have received an allogeneic HSCT within 90 days of
- •enrollment or who have active graft-versus-host disease requiring active
- •therapy and have a donor
- •5. Patients who are eligible for an allogeneic HSCT per the opinion of the
- •investigator and have a donor. Patients who are HSCT-eligible in the
- •opinion of the investigator, but who refuse a transplant, are eligible for
- •6. Patients who have received immunosuppressive therapy for graftversus-
- •host disease within 1 month prior to enrollment into this study
- •7. Patients with acute promyelocytic leukemia
- •8. Patients with a history of bleeding diathesis
- •9. Patients with known active CNS involvement with AML
- •10. Concurrent anticancer treatment, such as chemotherapy,
- •cytoreductive therapy, immune therapy, or cytokine therapy within 14
- •days of the first dose of KRT-232, provided they have recovered from
- •treatment toxicity. Patients on hydroxyurea may continue therapy with
- •hydroxyurea until the day before starting therapy on this study. Patients
- •on FLT3 inhibitors may continue therapy with FLT3 inhibitors until the
- •day before starting therapy on this study. Subjects on JAK inhibitors
- •should be tapered off JAK inhibitor therapy prior to starting treatment on
- •this study per the JAK inhibitor tapering guidelines outlined in Section
- •7.4.1 of this protocol.
- •11. Patients previously treated with MDM2 antagonist therapies
- •12. Patients who have had major surgery within 28 days prior to the first
- •treatment with KRT-232
- •13. Women who are pregnant or breastfeeding
- •14. Uncontrolled intercurrent illness including, but not limited to, known
- •active hepatitis A, B, or C; known history of human immunodeficiency
- •virus (HIV)-positive; 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
- •15. Subjects with uncontrolled bacterial, fungal, parasitic, or viral
- •infection. Subjects with acute bacterial infections requiring antibiotic use
- •should not enroll until the infection is stable in the judgement of the
- •treating physician; these patients may be on antibiotics at enrollment.
- •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 NCICTCAE
- 另有 1 项未显示
研究者
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