Open label randomized bioequivalence study to evaluate the pharmacokinetic (PK) and safety profile of Bevacizumab Biosimilar (BEVZ92) in combination with FOLFOX or FOLFIRI versus Bevacizumab (AVASTIN®) in combination with FOLFOX or FOLFIRI as first-line treatment in patients with metastatic ColoRectal Cancer (mCRC).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- MABXIENCE SA
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To compare the PK profile of Bevacizumab and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI.
研究概览
简要总结
Thestudy is Open label randomizedbioequivalence study to evaluate the pharmacokinetic (PK) and safety profile ofBevacizumab. Biosimilar (BEVZ92) in combination with FOLFOX or FOLFIRI versusBevacizumab (AVASTIN®) in combination with FOLFOX or FOLFIRI as first linetreatment in patients with metastatic ColoRectal Cancer (mCRC). This study will be initiated only after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC), clinical trial permission from the Drug Controller General of India (DCGI). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study. The recruitment will happen as per randomization schedule. Randomization list will be generated by computer generated randomization number.Thestudy will be an open label study. All the Response assessment for the enrolledpatients will be based on RECIST Criteria Version 1.1. Thestudy will be conducted in 6 patients to determine the infusion toxicities. These patients will be reviewed by the DSMB. If there are no clinically significant or higher incidences of infusion reactions, the participants will continue to receive the therapy and complete the 7 cycles as per the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients must have signed an informed consent before any study related procedure or evaluation is performed.
- •2.Patients must be > 18 years of age.
- •3.Patient must not have had prior chemotherapy for advanced or metastatic disease.
- •4.Patient with mCRC for whom bio-chemotherapy is indicated.
- •5.Patients must have at least one measurable non-irradiated site of disease according to RECIST criteria.
- •6.Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy.
- •7.ECOG performance status ≤ 2.
排除标准
- •1.Prior treatment for advanced or metastatic colorectal cancer.
- •2.Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
- •3.Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
- •4.History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
- •5.Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
- •6.Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
- •7.Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- •8.Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
结局指标
主要结局
To compare the PK profile of Bevacizumab and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI.
时间窗: Cycle 1: | 0 h(pre-infusion), end of infusion; 1 h, 2 h, 6 h, 24 h (D2), 48h (D3),72h (D4), 120h (D6), 168 h (D8) & 240 h (D11) after end of infusion.Cycle 2- Cycle 5: 0 h(pre-infusion), end of infusion on D1 of Cycles 2 and 5 | Cycle 7: | 0h, end of infusion; 1 h, 2 h, 6 h after end of infusion on | D1 and thereafter one sample at 24 h (D2), 48 h (D3), 72 h (D4), 120 h | (D6), 168 h (D8), 240 h (D11) after end of infusion | (Cycle 7)and 336 h(D15, just before the start of the bevacizumab of Cycle 8
次要结局
- Comparation the safety profile of Bevacizumab and Avastin®, both(administered in combination with FOLFOX (any) or FOLFIRI.)