KCT0009473尚未招募Unknown
COmbination of Bevacizumab and Erlotinib Therapy in EGFR overamplified metastatic colorectal cancer with resistance or intolerance to oxaliplatin and irinotecan-based chemotherapy - A single arm, phase 2, multicenter Study (COBET)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Patients with histologically/cytologically proven metastatic/recurrent colorectal cancer who have failed or are ineligible for standard chemotherapy based on oxaliplatin and irinotecan (subjects who have received adjuvant chemotherapy for colorectal cancer, and if the disease recurs during adjuvant chemotherapy or within 6 months after completion of adjuvant chemotherapy, adjuvant chemotherapy is considered as first-line palliative chemotherapy).
- •2.EGFR copy number gain of 4 or greater as identified by NGS testing conducted at participating institutions.
- •3.Presence of disease assessable by RECIST 1.1 criteria (measurable lesions are not essential for study inclusion).
- •4.Aged 19 years or older.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •6.Adequate organ and bone marrow function as defined by:
- •7.Absolute neutrophil count (ANC) = 1.0 x 10^9/L
- •-Hemoglobin (Hgb) = 9.0 g/dL
- •-Platelet count = 75 x 10^9/L
- •-Serum creatinine = Upper Limit of Normal (ULN) x 1.5 or creatinine clearance > 30 mL/min
- •-Total bilirubin: = 2.0 × ULN, with appropriate biliary drainage if subjects have biliary obstruction to meet criteria
- •-AST and ALT = 3 x ULN if no liver metastasis, or AST and ALT = 5 x ULN if liver metastasis present.
- •8.Adequate cardiac function: QTc =480 msec; if QTc exceeds 480msec, registration is allowed if the average QTc value is below 480msec based on 3 consecutive measurements.
- •9.Ability to swallow oral medication.
- •10.For fertile female patients, negative serum ß-HCG test within 14 days before initiation of investigational drug administration.
- •11.Subjects must comply with appropriate contraceptive methods.
- •Fertile female subjects (all women of childbearing potential who are not using adequate contraception during the trial and for 4 weeks after discontinuing trial therapy) must use the following contraception methods to be eligible for enrollment:
- •Abstinence from all forms of sexual intercourse and consistent abstinence is recommended in daily life. Periodic abstinence (e.g., rhythm method, mucus pattern, temperature method, etc.) and withdrawal are not acceptable contraceptive methods.
- •Female sterilization procedures: hysterectomy with or without bilateral salpingo-oophorectomy; bilateral oophorectomy with or without hysterectomy performed at least 6 weeks before enrolling in this trial. Bilateral oophorectomy is permitted only if the subject's potential for pregnancy is confirmed by hormonal assessments.
- •Vasectomized partner (at least 6 months prior to screening). Male partners who have undergone vasectomy must be the sole partner of women participating in the trial during their participation.
- •Men should use condoms during sexual intercourse while on investigational drug treatment and for up to 1 month after discontinuing treatment (up to 1 month after the last dose).
- •12.Life expectancy of more than 3 months.
- •13.Subjects must sign the Informed Consent Form (ICF) before initiating any study-related tests or procedures.
排除标准
- •1.Pregnant or lactating women.
- •2.History of EGFR tyrosine kinase inhibitor + anti-VEGF blockade combination therapy (single-agent anti-VEGF blockade or combination with chemotherapy allowed).
- •3.Patients with hypersensitivity to any component of the investigational drug.
- •4.Within 14 days of receiving cytotoxic chemotherapy, receiving investigational drug in another clinical trial, within the last 2 weeks of the last dose, or within 4 weeks of a single clone antibody therapy.
- •5.Uncontrolled severe infection.
- •6.Severe medical conditions including active cardiac disease or psychiatric illness:
- •-Within 6 months of acute coronary syndrome (myocardial infarction or unstable angina, coronary artery bypass grafting, percutaneous coronary intervention including stent placement).
- •-New York Heart Association (NYHA) functional classification of heart failure = grade 2 or heart failure requiring treatment.
- •-Left ventricular ejection fraction (LVEF) less than 50% on MUGA scan or echocardiogram (screening with MUGA scan or echocardiogram is not required if there is no history or symptoms).
- •-Persistently uncontrolled hypertension despite medication: systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg (medication allowed for blood pressure control prior to screening).
- •-Clinically significant cardiac arrhythmias, atrial fibrillation, and/or conduction abnormalities (congenital Long QT syndrome, complete heart block) and related history.
- •Any risk factor that prolongs QTc or increases the likelihood of arrhythmias despite medical therapy (heart failure, hypokalemia, congenital Long QT syndrome, history of Torsades de Pointes).
- •7.Active central nervous system lesions (radiologically unstable or symptomatic brain lesions). Registration is allowed if the patient has undergone radiation therapy or surgical treatment, the patient remains stable without steroid therapy, and there is evidence that the brain lesion has not progressed for more than 4 weeks. Patients with leptomeningeal metastases are excluded.
- •8.History of other primary cancers. Exceptions include:
- •-Non-melanoma skin cancer adequately treated (basal cell or squamous cell carcinoma), superficial cervical cancer, or stage I bladder cancer, completely resected thyroid cancer with no evidence of metastasis (wounds should be adequately treated before trial registration).
- •-Solid tumors treated with no evidence of disease recurrence at least 36 months before study initiation.
- •9.Failure of previous anticancer therapy to recover to grade 1 or less (excluding alopecia).
- •10.Received radiation therapy to more than 30% of bone marrow within 4 weeks or received palliative radiation therapy to limited areas within 2 weeks.
- •11.Received major surgery within 4 weeks of study initiation or not recovered from surgery-related adverse events.
- •12.Thromboembolic events within 6 months.
- •13.History or evidence of bleeding disorders.
- •14.Currently taking maximum doses of anticoagulants for therapeutic purposes.
- •15.Unhealed wounds, acute ulcers, or fractures.
- •16.Within 6 months, patients with abdominal perforation or gastrointestinal bleeding.
- •17.If proteinuria is = 2+ on urine dipstick test and 24-hour proteinuria is >1g.
- •18.History of major gastrointestinal surgery or pathological findings that may affect the absorption of investigational drugs.
- •19.Evidence of active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Enrollment is possible if li
研究者
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