CTRI/2014/11/005171已完成3 期
A Double Blind, Randomized, Active Controlled, Parallel Design, Comparative PK, Efficacy, Safety and Immunogenicity Study of Bmab-100 and Avastin®, both in Combination with XELOX Chemotherapy in Patients with Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 34
- 主要终点
- Single dose pharmacokinetic parameters for Bmab-100 and Avastin® in terms of AUC0-t and Cmax [Cycle 1]
研究概览
简要总结
This study is randomized, double blind, parallel group, multi-centre trial comparing the PK, safety efficacy and immunogenicity of Bmab100 with Avastin in combination with xelox chemotherapy in 146 patient for a duration of 18 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged 18 years and above
- •Histopathologically confirmed colorectal cancer.
- •Diagnosis of metastatic colorectal cancer which is not amenable to curative surgery and/or radiation
- •Part I of the study will include only patients who have received chemotherapy earlier for metastatic colorectal cancer [i.e. at least 1st line treatment failure mCRC patients].
- •Part II of the study will include only patients who have not received any treatment for metastatic colorectal cancer [i.e. only 1st line mCRC patients]
- •Measurable disease on radiological assessment according to RECIST 1.1 criteria
- •Patient is an eligible candidate for XELOX [capecitabine and oxaliplatin] chemotherapy and not suitable for surgery.
- •ECOG status 0 or 1 for part I of the study and ECOG status 0, 1 or 2 for part II of the study.
- •Have life expectancy of at least 4 months as per the investigator.
- •Women of childbearing potential and men must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) for the entire duration of the study from the time of screening and 4 months following the completion of therapy.
排除标准
- •Received prior chemotherapy for metastatic disease [chemotherapy for primary disease is acceptable] which is applicable for part II of the study only.
- •Prior treatment with bevacizumab
- •History of hemoptysis, thrombotic or hemorrhagic event in past 6 months
- •Therapeutic anticoagulation; regular use of aspirin (325 mg/day), NSAIDs or agents known to inhibit platelet function
- •Radiation therapy for metastatic disease or surgery within 1 month of randomization
- •Serious non-healing wound or bone fracture
- •Known hypersensitivity to bevacizumab, capecitabine or oxaliplatin
- •Uncontrolled hypertension [defined as either systolic blood pressure 150 mm of Hg or diastolic blood pressure 100 mm of Hg]
- •Urine protein on dipstick analysis ≥ 2+ [If urine protein is ≥2+, further assessments should show urine protein:creatinine ratio 0.5 grams protein per gram creatinine by urinalysis OR total urinary protein 1,000 mg by 24-hour urine collection for inclusion]
- •Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •High levels of SGOT 3 x ULN and 5 x ULN in patients with liver metastasis.
- •Serum bilirubin 1.5 X ULN.
- •Hemoglobin 9 gm/dl or platelets 100,000/μl (with no blood and/ or packed cell transfusion within 2 weeks).
- •Patients with known or suspected brain metastases.
- •Patients with a history of CNS metastases are eligible if they have been successfully treated and are off steroids for at least 4 weeks before randomization.
- •Patients with history of prior malignancy other than colorectal cancer.
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer and successfully treated cervical carcinoma in situ.
- •Patients with severe renal impairment (estimated creatinine clearance below 30 mL/min)
- •Patients with clinically significant or poorly controlled co-morbid conditions like endocrinological, renal, hepatic, cardiac, pulmonary, hematological, gastrointestinal, neurological or psychological disorder, which in the opinion of the investigator may jeopardize the safety of the patient during the study or may interfere with the evaluation of efficacy of the study medication.
- •Patient in the opinion of investigator is not capable of complying with study requirements.
- •Patients with current history of drug/alcohol abuse.
- •Patient is unable or unwilling to give a written informed consent.
- •Patient has participated in an investigational drug study within last one month.
结局指标
主要结局
Single dose pharmacokinetic parameters for Bmab-100 and Avastin® in terms of AUC0-t and Cmax [Cycle 1]
时间窗: Single dose pharmacokinetic parameters for Bmab-100 and Avastin® in terms of AUC0-t and Cmax [Cycle 1]
次要结局
- 1.Overall response rate (ORR) according to RECIST 1.1 guidelines [baseline to 18 weeks](2. Progression free survival (PFS) at 18 weeks)
研究者
研究点 (34)
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