CTRI/2024/04/066032招募中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. - NI
CuraTeQ Biologics Private Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
- •1. Male and female patients 18 years and above.
- •2. Histopathologically confirmed colorectal cancer.
- •3. Diagnosis of metastatic colorectal cancer which is not amenable to curative surgery and or radiation.
- •4. Patients who have not received any treatment for metastatic colorectal cancer [i.e. only 1st line mCRC patients].
- •5. Measurable disease on radiological assessment according to RECIST 1.1 criteria.
- •6. Subjects with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 at the time of screening and before the first infusion.
- •7. Have a life expectancy of at least 4 months as per the investigator.
- •8. 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.
- •9. 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.
- •10. 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
- •1. Received prior chemotherapy for metastatic disease [chemotherapy for primary disease is acceptable].
- •2. Prior treatment with bevacizumab.
- •3. History of haemoptysis, thrombotic or haemorrhagic event in the past 6 months.
- •4. Therapeutic anticoagulation; regular use of aspirin (325 mg per day), NSAIDs, or agents known to inhibit platelet function.
- •5. Radiation therapy for metastatic disease or surgery within 1 month of randomization.
- •6. Serious non-healing wound or bone fracture.
- •7. Known hypersensitivity to bevacizumab, capecitabine, or oxaliplatin.
- •8. 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.
- •9. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •10. High levels of SGOT 3 x ULN and 5 x ULN in patients with liver metastasis. Serum bilirubin 1.5 X ULN.
- •11. 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.
- •12. Patients with a history of prior malignancy other than colorectal cancer.
- •13. Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer and successfully treated cervical carcinoma in situ.
- •14. Patients with severe renal impairment (estimated creatinine clearance below 30 mL per min) study.
- •15. Patients with a current history of drug and alcohol abuse.
- •16. Patient in the opinion of the investigator is not capable of complying with the study.
- •17. The patient is unable or unwilling to give written informed consent.
- •18. The patient has participated in an investigational drug study within the last one month.
- •19. Receipt of IV antibiotics for infection within 14 days of randomization.
- •20. 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.
- •21. 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.
- •22. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV.
- •23. 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.
研究者
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