NCT06008119招募中3 期
A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a multicenter, randomized, open-label, Phase 3 study
详细描述
This is a multicenter, randomized, open-label, Phase 3 study to evaluate Tunlamatinib plus Vemurafenib versus Investigator's choice of Chemotherapy based treatment as controls in patients with BRAFV600E mutant Metastatic Colorectal Cancer (CRC) whose disease has progressed after 1 or more prior regimens in the metastatic setting.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- •Male or female patients with 18 to 70 years of age at time of informed consent;
- •Histological or cytologically confirmed metastatic CRC
- •Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)
- •Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central laboratory testing of BRAF mutation status.
- •Progression of disease after 1 or more prior regimens in the metastatic setting
- •At least 1 site of radiographically measurable disease by RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
- •Life expectancy ≥ 3 months;
- •Can swallow the medicine,
- •Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:
- •Be willing and able to complete all the study procedures and follow-up examinations.
排除标准
- •Exclusion Criteria:
- •Prior treatment with any BRAF and MEK inhibitor;
- •Known contraindication to receive the treatment of control arm (according to latest PI).
- •Symptomatic brain metastasis or leptomeningeal disease
- •History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
- •Known history of acute or chronic pancreatitis
- •Uncontrolled GI bleeding, Dysphagia，refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.
- •Serious cardiovascular disease , including uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia , deep vein thrombosis or pulmonary emboli or cerebrovascular events ≤ 6 months prior to starting study treatment;
- •History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
- •Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
- •Uncontrolled blood pressure despite medical treatment
- •Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
- •Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
- •Anti-HIV(+) , Anti-TP( +); Active hepatitis B or hepatitis C infection …….
研究组 & 干预措施
Control
Active Comparator
Investigators' choice
干预措施: Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab (Drug)
Experimental
Experimental
Tunlamatinib plus Vemurafenib
干预措施: Tunlametinib plus Vemurafenib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 12 months
defined as the time from first dose to the earliest documented disease progression or death due to any cause
次要结局
- Overall Response Rate（ORR）(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- Duration of Response（DOR）(up to 12 months)
- Overall Survival（OS）(up to 12 months)
研究者
研究点 (1)
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