CTRI/2015/05/005757已完成3 期
A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative, Parallel Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity and Pharmacokinetics of an Intravenous Infusion of Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Reference product, Roche) Administered in Combination with Standard Chemotherapy in Patients of Metastatic Colorectal Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 26
- 主要终点
- Disease control rate as per RECIST 1.1 criteria
研究概览
简要总结
This is an open label, randomized, multi-center, multiple-dose, parallel study to evaluate the safety and efficacy of intravenous infusion of Bevacizumab Test product (Hetero) and Reference product in treatment of metastatic colorectal cancer given along with standard chemotherapy regimen. The primary objective is to compare the DCR using RECIST 1.1 criteria between two formulations. The secondary objectives are to evaluate safety, compare the immunogenic potentials and estimation of VEGF from baseline to the end of chemotherapy cycles between two formulations of Bevacizumab (test and reference). Comparison of single dose pharmacokinetic characteristics at the end of first cycle of chemotherapy and quality of life in both the groups will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically pre-confirmed metastatic colorectal carcinoma, and not suitable for radical surgery, or radiotherapy at the inclusion time
- •No known brain metastases 3.Performance status.
- •ECOG 0 to 2 4.Life expectancy ≥ 6 months 5.Major surgery, open surgical biopsy or significant traumatic injury at least 4 weeks before randomization. If post-operative, recovered from the effects of surgery 6.No plan to administer radiation therapy or perform surgery for target lesions during study treatment. (Palliative surgeries or radiation therapy for non-target lesions allowed). 7.INR ≤ 1.5 and aPTT ≤ 1.5 x ULN within 21 days prior to starting study treatment. 8.Adequate liver function: Serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN) 9.Adequate bone-marrow function 10.Ability to comply with study and follow-up procedures and provide written informed consent.
排除标准
- •Drug allergy, hypersensitivity or intolerance: Known or suspected allergy or hypersensitivity to any component of Bevacizumab
- •Any anticancer treatment (chemotherapy, hormonal treatment, radiation treatment, surgery, immunotherapy, biologic therapy or tumor embolization) within 4 weeks before randomization
- •Presence of a serious, non-healing wound, ulcer, or bone fracture
- •Chronic, actual or recent use (10 days prior to first drug administration) of acetylsalicylic acid (aspirin) >325 mg/day or clopidogrel (75 mg/day) or other treatments that can cause gastrointestinal ulcer (low-dose aspirin is permitted < or equal to 325 mg/day)
- •History of stroke or transient ischemic attack within 6 months prior to study enrolment
- •History or clinical evidence of uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on repeated measurement) despite optimal medical management
- •Cardiac arrhythmia
- •Any medical, psychological, or social condition that may interfere with the subjects participation in the study or evaluation of the study results.
结局指标
主要结局
Disease control rate as per RECIST 1.1 criteria
时间窗: At baseline and end of treatment cycles
次要结局
- Immunogenicity- Anti-Bevacizumab antibodies(Pharmacokinetic parameters (e.g., Cmax, Tmax & AUC etc.) Exploratory parameters- Estimation of VEGF levels)
研究者
研究点 (26)
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