NCT03545711Unknown1 期
Safety and Efficacy of Irinotecan Combined With Anlotinib in Patients With Pretreated Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •willing and able to provide written informed consent and comply with the requirements of the study
- •histologically- or cytologically-confirmed advanced colorectal cancer
- •failed or intolerable to at least one prior therapy
- •have evidence of measurable disease per RECIST v1.1
- •Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
- •weight ≥40kg
- •life expectancy >12 weeks
排除标准
- •Subjects meeting any of the following criteria are ineligible for participation in the study:
- •history of any anti-cancer therapy (including investigational agents) within 28 days prior to study entry
- •presence of toxicity of prior anti-cancer therapy that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
- •symptomatic brain metastasis requiring active treatment
- •any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry
- •active or clinically unstable infection requiring systemic therapy
- •unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs
- •active digestive ulcer disease, inflammatory bowel disease, intestinal obstruction or any other condition that, in the clinical judgment of the Principal Investigator, may cause severe gastrointestinal bleeding or perforation
- •unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤2 months prior to study entry
- •history of stroke or transient ischemic attack (TIA) within 12 months prior to study entry
- •any of the following abnormal findings in organ or marrow function 1 week prior to study entry:
- •Leukocytes < 1.5*10^9/L, or Platelets < 100*10^9/L, or Hb< 90g/L
- •Total bilirubin > 1.5 × institutional upper limit of normal (ULN), or AST (aspartate amino transferase)/ALT (alanine amino transferase)> 3 × institutional ULN for liver metastases, > 1.5 × institutional ULN in case of no liver metastases
- •any electrolyte imbalance of clinical significance
- •creatinine > institutional ULN and creatinine clearance < 60 mL/min
- •spot urine protein ≥(2+) or 24-hour proteinuria ≥1.0g/24h
- •APTT (activated partial thromboplastin time) or INR (international normalized ratio for prothrombin time) > 1.5 × institutional ULN
- •treatment refractory hypertension defined as a blood pressure of systolic> 140 millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg which cannot be controlled by a single anti-hypertensive agent
- •LVEF (left ventricular ejection fraction ) <50%
- •history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA)
- •present with non-healing fractures of bone or wounds of skin
- •pregnant or lactating female
- •sexually active female (of childbearing potential) or male unwilling to adopt an effective method of birth control during the course of the study
- •serious and/or unstable pre-existing psychiatric disorder
- •familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol
- •known immediate or delayed hypersensitivity reaction to anlotinib, irinotecan or their excipients
- •administration of irinotecan in prior treatments
研究组 & 干预措施
Anlotinib plus Irinotecan
Experimental
干预措施: Anlotinib Hydrochloride with Irinotecan (Drug)
结局指标
主要结局
MTD
时间窗: 6 months
the maximum tolerated dose (MTD) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
ORR
时间窗: 18 months
the overall response rate (ORR) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
次要结局
- DCR(18 months)
- PFS(18 months)
研究者
Jing Huang
Professor
Chinese Academy of Medical Sciences
研究点 (1)
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