A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR)[Part 1]
研究概览
简要总结
This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.
详细描述
This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Males and/or females over age 18
- •Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >3 months.
- •previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.
- •Inadequate organ or bone marrow function.
- •Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Part 1;50mg
干预措施: MAX-40279-01 (Drug)
Part 1;70mg
干预措施: MAX-40279-01 (Drug)
Part 2;MAX-40279-01
干预措施: MAX-40279-01 (Drug)
Part 2;regorafenib
干预措施: regorafenib (Drug)
结局指标
主要结局
Disease control rate (DCR)[Part 1]
时间窗: Through study Part 1 completion, an average of 6 months
progress free survival(PFS)[Part 2]
时间窗: Through study Part 1 completion, an average of 6 months
次要结局
- overall survival (OS)(24 months)
- Tmax(Approximately 6 months)
- Safety and tolerability assessed by incidence and severity of adverse events(24 months)
- Objective response rate (ORR)(6 months (anticipated))
- Cmax(Approximately 6 months)
- AUC(Approximately 6 months)