NCT04581512招募中1 期
A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies
Ellipses Pharma11 个研究点 分布在 3 个国家目标入组 70 人开始时间: 2020年11月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
研究概览
简要总结
A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML
- •Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue
- •Ability to swallow and retain oral medication
- •Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening
- •In the opinion of the investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug
- •Patients with pathologically confirmed/documented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for/intolerant to) available approved therapies for their disease.
- •Patients with relapsed/refractory FLT3 WT AML.
- •Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients.
- •Mutation status of patients must be known at trial entry.
- •Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug
- •Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug
排除标准
- •Patients with any of the following will not be included in the study:
- •Disease Under Study and Prior Anticancer Treatment
- •Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy
- •Acute promyelocytic leukemia (FAB:M3)
- •Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment)
- •Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade
- •Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient.
- •Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks
- •Laboratory Parameters
- •Patient with any out-of-range laboratory values defined as shown below.
- •Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/ min
- •Inadequate liver function as demonstrated by
- •total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or
- •ALT ≥3 times the ULN or
- •AST ≥3 times the ULN or
- •AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia
研究组 & 干预措施
Module 1 EP0042
Experimental
Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.
干预措施: EP0042 (Drug)
Module 2 EP0042
Experimental
- Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML.
- Part B: To evaluate the safety, tolerability, of EP0042 in combination with a Bcl 2 inhibitor (venetoclax) + a hypomethylating agent (azacitidine) in patients with R/R FLT3 WT or newly diagnosed AML.
干预措施: EP0042 (Drug)
Module 2 EP0042
Experimental
- Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML.
- Part B: To evaluate the safety, tolerability, of EP0042 in combination with a Bcl 2 inhibitor (venetoclax) + a hypomethylating agent (azacitidine) in patients with R/R FLT3 WT or newly diagnosed AML.
干预措施: Venetoclax (Drug)
Module 2 EP0042
Experimental
- Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML.
- Part B: To evaluate the safety, tolerability, of EP0042 in combination with a Bcl 2 inhibitor (venetoclax) + a hypomethylating agent (azacitidine) in patients with R/R FLT3 WT or newly diagnosed AML.
干预措施: Azacitidine (AZA) (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
时间窗: First cycle of treatment (28 Days)
Incidence of dose-limiting toxicities (DLT)
次要结局
未报告次要终点
研究者
研究点 (11)
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