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Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

ABSTRACT: Interventions: Bevacizumab and irrinotecan based chemotherapy (q2w FOLFIRI, q3w XELIRI, q3w/q4w IRIS) Primary outcome(s): Progression free survival Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2625093 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Study drug: AB122 solution for infusion. This is a dose escalation study with up to 36 subjects testing safety, pharmacokinetics and pharmacodynamics. The study will consist of two parts, Part 1 and Part 2. In Part 1 three cohorts will be dosed 80, 240 and 720mg of AB122 respectively. Subjects will initially be assigned to the Q2W dosing schedule(every 2 weeks). The Q3W dosing schedule (every 3 weeks) will be considered if de-escalation is required. Part 2 will confirm Pharacokinetic and Pharmacodynamics from Part 1. Dosing will either occur every 2, 3 or 4 weeks (Q2W, Q3W or Q4W respectively) there by subjects will be administered 2 doses of study drug per cycle for the Q2W schedule and one dose of study drug per cycle for the Q3W and Q4W schedules. Cycles for Q2W and Q4W dosing are 28 days, and Q3W dosing Cycle is 21 days. Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol. Primary outcome(s): To evaluate the safety and tolerability of AB122 in subjects with advanced solid tumors. The Incidence of adverse events (AEs) and dose-limiting toxicities (DLTs) will be measured by clinical examination. [Recorded at baseline (screening), on days 1, 2, 3, 8, 15 and then every 2 weeks on treatment, at end of treatment and every 30 days until 6 months post dose (i.e. at 30, 60 and 90 days, and 6 months) for Q2W and Q4W dosing schedules. Recorded at baseline (screening), on days 1, 2, 3, 8, 22 and then every 3 weeks on treatment, at end of treatment and every 30 days until 6 months post dose (i.e. at 30, 60 and 90 days, and 6 months) for Q3W dosing schedule.];To evaluate the safety and tolerability of AB122 in subjects with advanced solid tumors. Safety and clinical laboratory parameters (biochemistry, hematology and urinalysis) will be measured by blood and urine analysis.[Recorded at baseline (screening), on days 1, 2, 3, 8, 15 and then every 2 weeks on treatment, at end of treatment and every 30 days until 6 months post dose (i.e. at 30, 60 and 90 days, and 6 months) for Q2W and Q4W dosing schedules. Recorded at baseline (screening), on days 1, 2, 3, 8, 22 and then every 3 weeks on treatment, at end of treatment and every 30 days until 6 months post dose (i.e. at 30, 60 and 90 days, and 6 months) for Q3W dosing schedule.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used)

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Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

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