2024-514588-24-00暂停2 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 Pharma Limited2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年5月16日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Module 1 Primary Endpoints: 1. Incidence of DLT, adverse events (AEs), serious adverse events (SAEs) and changes in laboratory parameters, physicalexamination, vital signs and electrocardiograms (ECGs).
研究概览
简要总结
Core Primary Objectives:
- To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments.
Module 1 Primary Objectives:
- To investigate the safety and tolerability of EP0042 given as a monotherapy in patients with relapsed or refractory (R/R) AML(AML, MDS or CMML).
Module 2 Primary Objectives:
- 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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Core Inclusion Criteria:
- •Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytologicalconfirmation of leukemia.
- •Ability to understand and provide written informed consent before any study-specific procedures, sampling, oranalyses, including access to archival tumor tissue.
- •Ability to swallow and retain oral medication.
排除标准
- •Core Exclusion Criteria:
- •Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy.
- •Ongoing toxic manifestations of previous treatments that have not reduced to at least Common Terminology Criteria for Adverse Events (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.
- •Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min.
- •Receiving an investigational anti-cancer treatment concurrently or within 14 days or five half-lives of either the parent drug or any active metabolite prior to the start of treatment with EP
- •Patients with AML may receive hydroxyurea throughout the screening period and during the first 2 cycles of study treatment in the first module(FIH study).
- •Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal(GI) function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery such as gastric bypass.
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection.
- •Patients with active human immunodeficiency virus infection (HIV) infection (testing is not required). Patients living with HIV will be eligible if they have CD4+ T-cell count ≥ 350 cells/μL, no history of AIDS-defining opportunistic infections in the past 12 months, and can be managed on a regimen consistent with this protocol's permitted concomitant medications.
- •Malignant disease other than that being treated in this study, with the following exceptions: a. Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment. b. Completely resected basal cell and squamous cell skin cancers. c. Any malignancy considered to be indolent and that has never required therapy. d. Completely resected carcinoma in situ of any type.
- •Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.
- •Any major surgical procedure (in the investigator's judgement) within 2 weeks of the first dose of study drug.
- •Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
研究组 & 干预措施
Venclyxto 100 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 100 mg film-coated tablets (Drug)
Venclyxto 100 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 10 mg film-coated tablets (Drug)
Venclyxto 100 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 50 mg film-coated tablets (Drug)
Vidaza 25 mg/ml powder for suspension for injection
Test
干预措施: Vidaza 25 mg/ml powder for suspension for injection (Drug)
null, null
Test
干预措施: null, null (Drug)
结局指标
主要结局
Module 1 Primary Endpoints: 1. Incidence of DLT, adverse events (AEs), serious adverse events (SAEs) and changes in laboratory parameters, physicalexamination, vital signs and electrocardiograms (ECGs).
Module 1 Primary Endpoints: 1. Incidence of DLT, adverse events (AEs), serious adverse events (SAEs) and changes in laboratory parameters, physicalexamination, vital signs and electrocardiograms (ECGs).
Module 2 Primary Endpoints: 1. Incidence of DLTs, AEs, SAEs and changes in laboratory parameters, physical examination, vital signs and electrocardiograms.
Module 2 Primary Endpoints: 1. Incidence of DLTs, AEs, SAEs and changes in laboratory parameters, physical examination, vital signs and electrocardiograms.
次要结局
- Module 1 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) after single and multiple doses 2. Best overall response (BOR) 3. Duration of response (DOR) 4. Overall survival (OS)
- Module 2 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) of EP0042 and combinationagents after single and multiple doses. 2. BOR 3. DOR 4. Event free survival (EFS) 5. RFS 6. OS
研究者
Katie Stoddart
Scientific
Ellipses Pharma Limited
研究点 (2)
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