EUCTR2018-003857-73-GB进行中（未招募）1 期
A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
入选标准
- •Patients must meet all of the following criteria:
- •Part A Inclusion Criteria (dose escalation)
- •1. AML patients who have relapsed or are refractory to standard therapies (all patients)
- •2. AML patients who are unlikely to demonstrate rapid progression such that they would be unable to complete the first cycle of therapy (all patients)
- •3. Adults with previously untreated confirmed diagnosis of AML (bone marrow blasts = 20%) for whom monotherapy with AZD2811 is considered appropriate and are not suitable for intensive induction therapy based on the following (monotherapy and HMA combination patients):
- •=75 years, or
- •=75 years of age with clinically significant cardiac or pulmonary dysfunction unrelated to leukaemia, as reflected by at least 1 of the following criteria:
- •? Left ventricular ejection fraction (LVEF) =50%
- •? Diffusing capacity of the lungs for carbon monoxide (DLCO) =65% of expected
- •? Forced expiratory volume 1 (FEV1) =65% of expected
- •? Chronic stable angina
- •Part B Inclusion Criterion (dose expansion)
- •1. Adults with previously untreated confirmed diagnosis of AML per World Health Organization (WHO) and European Leukemia Net (ELN) criteria (bone marrow blasts = 20%) who are not suitable for intensive induction therapy based on the following:
- •= 75 years, or
- •=75 years of age with clinically significant cardiac or pulmonary dysfunction unrelated to leukaemia, as reflected by at least 1 of the following criteria:
- •? Left ventricular ejection fraction (LVEF) = 50%
- •? Diffusing capacity of the lungs for carbon monoxide (DLCO) = 65% of expected
- •? Forced expiratory volume 1 (FEV1) = 65% of expected
- •? Chronic stable angina
- •Inclusion Criteria for All Patients
- •1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses. If a patient declines to participate in any genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
- •2. Aged = 18 years
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •4. Prior treatment with hydroxyurea (up to 24 hours before study treatment) is allowed
- •5. Adequate organ system function as outlined below:
- •? PT/PTT =1.5 x upper limit of normal (ULN)
- •? Total bilirubin =1.5 x ULN. Patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) who have serum bilirubin = 3 x the ULN may be enrolled, unless there is evidence of hemolytic anemia
- •? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.5 ×x ULN if no liver involvement or = 5 times the ULN with liver involvement
- •? Creatinine = 1.5 x ULN, OR calculated or measured creatinine clearance = 50 mL/min as calculated by the Coc
排除标准
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled:
- •1. Treatment with:
- •? Any investigational agents, experimental antibody or antibody drug conjugates, or study drugs from a previous clinical study within 3-4 weeks prior to the first dose of study treatment in this study.
- •? Any other chemotherapy, immunotherapy or anticancer agents < 2 weeks of the first dose of study treatment.
- •? Any haematopoietic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) < 7 days of the first dose of AZD2811 monotherapy or with combination agent(s) or pegylated G-CSF (pegfilgrastim) or darbepoetin < 14 days of the first dose of study treatment.
- •? Prescription (Rx) or non-Rx drugs or other products known to be strong inhibitors/inducers of CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Washout periods should be a minimum of 5 half-lives depending on the medication.
- •? Patients who have undergone allogeneic stem cell transplant < 12 months are excluded. If allogeneic transplant was > 12 months ago, they are not excluded if they are off all immunosuppression and have no signs or symptoms of active graft vs. host disease.
- •? Major surgery (excluding placement of vascular access) < 4 weeks of the first dose of study treatment.
- •2. Any unresolved toxicities (except alopecia) from prior therapy greater than CTCAE Grade 1.
- •3. Presence of, or history of leptomeningeal disease.
- •4. As judged by the Investigator, any evidence of: severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or other malignancy (like advanced malignant hepatic tumours); current unstable or uncompensated respiratory or cardiac conditions; or uncontrolled hypertension; history of, or active, bleeding diatheses (e.g., haemophilia or von Willebrand disease); patients with inflammatory bowel disease (e.g., Crohn or colitis ulcerosa); uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment); or IV anti-infective treatment within 2 weeks before first dose of study treatment unless clear evidence would indicate that despite the clinical symptoms no infection took place.
- •5. Any of the following cardiac criteria:
- •? Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II
- •? Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •? Unstable angina or new-onset angina
- •? QTcF interval > 450 ms (for male subjects) or >470 ms (for female subjects) on screening ECG
- •6. Active non-infectious skin disease (including rash, dermatitis, or psoriasis, but excluding stable plaque psoriasis from the definition of active di
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