EUCTR2016-003301-34-BG进行中（未招募）1 期
A Randomized, Double-blind, Multicentric, Parallel-group Study Comparing Efficacy, Safety and Immunogenicity of CBT124, a Candidate Biosimilar Bevacizumab in Combination with Carboplatin and Paclitaxel with EU sourced Avastin® in Combination with Carboplatin and Paclitaxel in First line Treatment for Subjects with Stage IV (Unresectable Recurrent Disease or Metastatic) Non-squamous Non-Small Cell Lung Cancer (NSCLC) - Efficacy, Safety & Immunogenicity Study of CBT124 & EU-sourced Avastin®
Cipla BioTec Pvt. Ltd.0 个研究点目标入组 200 人开始时间: 2016年10月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult subjects aged = 18 to 75 years (= 18 to 65 years for India) with histologically or cytologically confirmed advanced non-squamous NSCLC.
- •Epidermal growth factor receptor (EGFR) negative or wild type
- •Stage IV (Unresectable recurrent disease or metastatic) NSCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •Evaluable disease status or measurable tumor
- •Adequate hepatic, renal, and bone marrow function
- •Subjects with pre-existing hypertension must be well controlled on a stable regimen of antihypertensive therapy. Have systolic blood pressure = 140 and = 90 mmHg, diastolic blood pressure = 90 and = 50 mmHg and heart rate = 40 and = 90 bpm at screening and admission.
- •Ability to understand risks of participation in the study and willingness provide informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Small cell lung cancer (SCLC) or combination of SCLC and NSCLC.
- •Squamous-cell tumors and mixed adenosquamous carcinomas of
- •predominantly squamous nature
- •Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab
- •Prior therapy with carboplatin or paclitaxel
- •Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally-advanced NSCLC if completed <12 months prior to screening
- •Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the Investigator is likely to bleed
- •Symptomatic brain metastasis
- •Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
- •Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
- •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Thrombotic or hemorrhagic event = 6 months prior to screening
- •History of hemoptysis greater than ½ teaspoon of bright red (fresh) blood in the past 4 weeks
- •Subjects receiving long-term aspirin (> 325 mg/day), or other nonsteroidal anti-inflammatory agents, or other drugs known to inhibit platelet function, treatment with dipyridamole, ticlopidine, or clopidogrel
- •Subjects receiving anticoagulants
- •Subjects who plan to undergo surgery during the study period
- •Subjects who have undergone a major surgery, or have had a
- •significant traumatic injury within 4 weeks prior to randomization
- •Subjects who have a significant non-healing wound, or bone fracture within 4 weeks prior to randomization
- •Subjects with history of gastrointestinal perforation or fistula formation
- •Subjects with known hypersensitivity to any of the ingredients of the investigational products, or mammalian cell-derived products
- •Female subjects who are pregnant, breast-feeding, planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e., bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
- •Male subject with a partner of childbearing potential who does not consent to the use of a reliable method of double contraception
- •Subjects with uncontrolled hypertension
- •Subjects with active infection assessed to be clinically significant by Investigator
- •Known history of, or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody [HCVAb]) or hepatitis B virus (test for Hepatitis B surface Antigen [HBsAg])
- •History of alcohol or substance abuse
- •Prior treatment with any investigational drug within the 30 days prior to screening, or within 5 half-lives of the drug, whichever is longer
- •Inability to comply with study requirements
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
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