A multicenter open-label, single arm, phase IV clinical trial to evaluate the safety and efficacy of KRABEVA®/Abevmy® administered as per the prescribing information in patients with solid tumors.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 20
- 主要终点
- Incidence, nature and severity of adverse events causally related to bevacizumab
研究概览
简要总结
Thisis a multicentre, single arm, open label phase IV study to evaluate the safetyand efficacy of bevacizumab(KRABEVA® / Abevmy® )intravenous infusion administered as per the prescribinginformation. The study will consist of a 21-day screening period, study drugtreatment cycles every 2 weeks or 3 weeks, lasting for a period of up to 6months. Approximately 225 patients will be enrolled. The study populationwill comprise of the patients with solid tumors who have passed screeningassessments, have provided written informed consent and considered eligible to receive bevacizumab treatment as per the prescribing information ofbevacizumab as per the investigator. The patient will continue to receivebevacizumab for a maximum period of 6 months after initiation of bevacizumab,or until disease progression, death, unacceptable toxicity or withdrawal due toany cause, whichever is earliest .During the study the safety assessments willbe conducted at recommended intervals as in the schedule of assessments. Patientswho meet the inclusion/exclusion criteria will be included in the study. Thepatients will receive bevacizumab intravenous infusion (dosage range of 5 mg/kgto 15 mg/kg body weight) in every 2 weeks or every 3 weeks cycles with orwithout background chemotherapy or other cancer treatment as specified forrespective indications in the prescribing information of bevacizumab and/or asper the standard practice of the site followed by the investigator. Recommendedefficacy assessments include CT scan/MRI, chest X-ray and any additional scansrequired for assessment of disease status of the patient. These may beperformed at the visits recommended in the schedule of assessments (per theNCCN guideline recommendations for the specific indications) and / or as perthe site standard practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and non-pregnant, non-lactating females of age 18 years and above 2.Patients with indicated malignancies eligible to receive bevacizumab as per the prescribing information and judgement of the investigator 3.Adequate bone marrow, liver and renal function (judged by the investigator based on investigations at screening) 4.ECOG of 0, 1 or
- •5.All women of child bearing potential (i.e., ovulating, pre-menopausal) should use at least 2 reliable forms of contraception during the trial.
排除标准
- •1.Patients with known hypersensitivity to bevacizumab or other drugs required as part of treatment regimen for the malignancy.
- •2.History or presence of serious non-healing wound or active ulcer or untreated bone fracture.
- •3.Presence of or history of severe haemorrhage hemoptysis within 3 months prior to bevacizumab administration; significant gastrointestinal bleeding; intracranial hemorrhage or significant pathological vaginal bleeding.
- •4.Presence or history of severe arterial or venous thrombotic or thromboembolic events within the 6 months prior to first dose of bevacizumab in the trial.
- •5.History of gastrointestinal fistula/abscess/perforation or other fistula.
- •6.Tumor location known to be in close contact with major vessels, especially NSCLC 7.Presence of incompletely healed surgical wound at the time of first dosing of bevacizumab in the study.
结局指标
主要结局
Incidence, nature and severity of adverse events causally related to bevacizumab
时间窗: Up to 6 months ( throughout the study)
次要结局
- 1.Proportion of patients discontinuing Bevacizumab and/or chemotherapy /other cancer treatment due to adverse events related to bevacizumab.(2.Evaluation of efficacy parameters such as Progression Free Survival (PFS), Time to progression (TTP), Disease Control Rate (DCR), overall response rate (ORR), Duration of Response (DR))