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
- 248
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
入选标准
- •Patient of both sex aged ââ?°Â¥ 18 years
- •2. 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
- •3. 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
- •4. Bidimensionally measurable lesion according to RECIST 1.1 criteria
- •5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of ââ?°Â¤2
- •6. Life expectancy of 12 weeks or more
- •7. Patients able to understand the investigational nature of this study and give written informed
- •consent prior to the participation in the trial
- •8. Able to comply with study requirement in opinion of Principal Investigator
排除标准
- •Pregnant and lactating women
- •2. 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
- •3. History of clinically significant cardiac diseases (e.g., uncontrolled hypertension, myocardial
- •infraction, unstable angina, NYHA ââ?°Â¥2 congestive heart failure, or serious cardiac arrhythmia)
- •in past six months
- •4. 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
- •5. 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
- •6. History of surgery in past 4 weeks or planned elective surgery, fine needle biopsy, or an open
- •biopsy within past one week
- •7. Any other medical conditions (including mental illness, substance abuse, social situations)
- •deemed by the clinician
- •8. Patients with CNS metastasis
- •9. Gross hemoptysis (ââ?°Â¥1/2 tsp red blood) or hematuria or hematemesis within 3 months
- •10. Absolute neutrophil count <1500/mm3
- •11. Platelets <100000/mm3
- •12. Creatinine level ââ?°Â¥1.5 mg/dL
- •13. Bilirubin level ââ?°Â¥1.5 Ã?â?? upper limit of normal (ULN)
- •14. Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ââ?°Â¥2.5 Ã?â?? ULN (ââ?°Â¥5
- •Ã?â?? ULN for patients with liver metastases)
- •15. Alkaline phosphatase level ââ?°Â¥5 Ã?â?? 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. H. Jani
- •Protocol No. BEV.14.001.02.PROT
- •Version No.: 2.0
- •16. Patient with non-healing wounds, ulcers or bone fractures
- •17. History of serious and / or severe infections such as Hepatitis C virus, hepatitis B virus, HIV
- •infections, tuberculosis, etc.
- •18. Simultaneous participation in other clinical trials, previous participation in other clinical trials
- •within 3 months before entering into the trial
研究者
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