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A clinical trial to study the safety and efficacy of biosimilar Bevacizumab in patients with metastatic colorectal cancer.

ABSTRACT: Intervention1: Biosimilar Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Control Intervention1: Innovator Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Primary outcome(s): To compare the efficacy of Biosimilar Bevacizumab versus Innovator Bevacizumab, both in Combination with CAPEOX in patients with metastatic colorectal cancer (mCRC) by assessment of best Overall Response Rate (ORR)Timepoint: All patients completed 12 week of treatment. Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified

PROVIDER: 2596365 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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