CTRI/2015/08/006109已完成3 期
A Prospective, Randomized, Multi-Center Study to Compare the Safety,Tolerability and Efficacy of Bevacizumab (Zydus Cadila) WithBevacizumab (Avastin®) in Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 27
- 主要终点
- Comparison of best overall response rate (ORR) following bevacizumab (Test Product, Zydus)
研究概览
简要总结
This is an A Prospective, Randomized, Multi-Center Study to Compare the Safety,Tolerability and Efficacy of Bevacizumab (Zydus Cadila) With Bevacizumab (Avastin®) in Non-Small Cell Lung Cancer (NSCLC) with Immunogenicity Assessment Extension study
The purpose of this study is to determine safety, tolerability, efficacy of bevacizumab (Test Product, Zydus) vs. bevacizumab (Reference Product, Roche/Genentech), in patients with unresectable, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
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
- •Patient of both sex aged ≥ 18 years
- •Patient with history of histologically or cytologically confirmed non-squamous non-small cell lung cancer (defined as stage IIIB with malignant pleural effusion, stage IV, or recurrent disease)
- •Patients with advanced, unresectable or metastatic non-squamous NSCLC suitable for treatment with Bevacizumab, carboplatin and paclitaxel (BV and CP) therapy as a first line therapy
- •Bidimensionally measurable lesion according to RECIST 1.1 criteria
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
- •Patients able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial
- •Able to comply with study requirement in opinion of Principal Investigator.
排除标准
- •Pregnant and lactating women
- •Patient who have received prior chemotherapy or biotherapy, radiotherapy to an area measurable disease (unless disease progression is documented following completion of the therapy) or radiotherapy within past 2 weeks
- •History of clinically significant cardiac diseases (e.g., uncontrolled hypertension, myocardial infraction, unstable angina, NYHA ≥2 congestive heart failure, or serious cardiac arrhythmia) in past six months
- •History of serious or severe arterial thrombotic events and/or venous thromboembolic events (cerebral infarction, myocardial infarction, stroke, active symptomatic peripheral vascular disease; deep vein thrombosis, pulmonary embolism or proven coagulopathy in past three months.
- •Recent or current use of aspirin or oral and/or parental anticoagulants (except low dose Coumadin 1 mg), known hypersensitivity to any components of the study medications and ingredients
- •History of surgery in past 4 weeks or planned elective surgery, fine needle biopsy, or an open biopsy within past one week
- •Any other medical conditions (including mental illness, substance abuse, social situations) deemed by the clinician
- •Patients with CNS metastasis
- •Gross hemoptysis (≥1/2 tsp red blood) or hematuria or hematemesis within 3 months
- •Absolute neutrophil count <1500/mm3
- •Platelets <100000/mm3
- •Creatinine level ≥1.5 mg/dL
- •Bilirubin level ≥1.5 × upper limit of normal (ULN)
- •Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN (≥5 × ULN for patients with liver metastases)
- •Alkaline phosphatase level ≥5 × ULN Cadila Healthcare Limited CLINICAL TRIAL PROTOCOL BEV.14.001.02.PROT CONFIDENTIAL PAGE 7 OF 80 Prepared by: Dr. Jayeshkumar Bhatt Approved by: Dr. R.
- •Jani Protocol No. BEV.14.001.02.PROT Version No.: 2.0
- •Patient with non-healing wounds, ulcers or bone fractures
- •History of serious and / or severe infections such as Hepatitis C virus, hepatitis B virus, HIV infections, tuberculosis, etc.
- •Simultaneous participation in other clinical trials, previous participation in other clinical trials within 3 months before entering into the trial.
结局指标
主要结局
Comparison of best overall response rate (ORR) following bevacizumab (Test Product, Zydus)
时间窗: Time Point :-Day 127
and bevacizumab (Reference Product) treatment in patients with non-squamous non-small cell
时间窗: Time Point :-Day 127
lung cancer
时间窗: Time Point :-Day 127
次要结局
- Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus)(and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with)
研究者
研究点 (27)
Loading locations...
相似试验
Unknown
不适用
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV FistulaArteriovenous FistulaNCT04393688BrosMed Medical Co., Ltd168
招募中
不适用
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation LesionsCoronary Bifurcation LesionNCT06618248Dongguan TT Medical280
已完成
不适用
TC-A Registration StudyPrimary OsteoarthritisRheumatoid ArthritisAvascular NecrosisPost-traumatic ArthritisNCT02139345Smith & Nephew Medical (Shanghai) Ltd162
进行中（未招募）
不适用
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)Aortic Valve StenosisHeart Valve DiseasesNCT04160130Optimapharm432
终止
不适用
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental GlomerulosclerosisFSGSNCT01451489Nanjing University School of Medicine70