CTRI/2024/04/066032进行中（未招募）3 期
A Prospective, Randomized, Double Blind, Multicentric, Parallel Group Phase-III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of BP01 (Bevacizumab) Versus EU approved Avastin® along with chemotherapy XELOX in metastatic colorectal cancer patients.
CuraTeQ Biologics Private Ltd27 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2024年4月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
- 试验地点
- 27
- 主要终点
- Objective response rate (ORR) as per RECIST Version 1.1
研究概览
简要总结
Colorectal cancer (CRC) commonly known as colon cancer, or rectal cancer is characterized by the uncontrolled proliferation of cells in the colon or rectum. It is the third most common cancer and the fourth most common cause of cancer-related death. Most cases of CRC are detected in Western countries, with its incidence increasing year by year. An aging population, unfavorable diet, smoking, sedentary lifestyle, chronic disease, low physical activity, and obesity are a few factors that contribute to the risk of colorectal cancer in developed countries.
This is a Prospective Phase III, Multicentric, Comparative, Randomized, Double-blind, Active Controlled, Parallel group clinical study to evaluate and compare the efficacy, immunogenicity and safety of BP01(Bevacizumab) mfg. by CuraTeQ Biologics Private Limited with reference medicinal product EU approved Avastin® (Bevacizumab of Roche) along with chemotherapy XELOX in metastatic colorectal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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 18 years and above.
- •Histopathologically confirmed colorectal cancer.
- •Diagnosis of metastatic colorectal cancer which is not amenable to curative surgery and or radiation.
- •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.
- •Subjects with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 at the time of screening and before the first infusion.
- •Have a life expectancy of at least 4 months as per the investigator.
- •The Patient is able to understand and is willing to give informed consent and is able to comply with the requirements of the study protocol.
- •A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta-hCG]) at screening and urine beta-hCG test at randomization.
- •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].
- •Prior treatment with bevacizumab.
- •History of haemoptysis, thrombotic or haemorrhagic event in the past 6 months.
- •Therapeutic anticoagulation; regular use of aspirin (325 mg per 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.
- •Urine protein on dipstick analysis ≥ 2+ [If urine protein is more than 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.
- •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 a history of prior malignancy other than colorectal cancer.
- •Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer and successfully treated cervical carcinoma in situ.
- •Patients with severe renal impairment (estimated creatinine clearance below 30 mL per min) study.
- •Patients with a current history of drug and alcohol abuse.
- •Patient in the opinion of the investigator is not capable of complying with the study.
- •The patient is unable or unwilling to give written informed consent.
- •The patient has participated in an investigational drug study within the last one month.
- •Receipt of IV antibiotics for infection within 14 days of randomization.
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- •Received an investigational intervention (including investigational live vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives before the Baseline, whichever is longer, before signing the consent.
结局指标
主要结局
Objective response rate (ORR) as per RECIST Version 1.1
时间窗: Day 127
次要结局
- Objective response rate (ORR)(Day 64)
- Overall survival(Day 127)
- Progression Free Survival(Day 127)
- Disease Control Rate(Day 127)
- Incidence and Titres of Anti-Bevacizumab Antibodies between both groups.(Baseline, Day 43 and Day 127)
- Treatment Emergent Adverse Events (TEAEs)(Day 127)
研究者
Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
研究点 (27)
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