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 (AVASTINÂ®) in combination with FOLFOX or FOLFIRI as first-line treatment in patients with metastatic ColoRectal Cancer (mCRC).

MABXIENCE SA0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
•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.

•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.

发起方