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A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy


ABSTRACT: Intervention type:DRUG Name of intervention:Lenvatinib Dose form / Japanese Medical Device Nomenclature:CAPSULE Route of administration / Site of application:ORAL Dose per administration:24mg 24mg 24mg Dosing frequency / Frequency of use:QD Planned duration of intervention:Treatment will continue until the discontinuation criteria are met. Intended dose regimen:24mg of lenvatinib is orally taken once daily for 28 days each course detailes of teratment arms:Treatment will continue with lenvatinib 24mg qd until the criteria of interruption, resuming, reduction and discontinuation of treatment are met. Dose of lenvatinib will be reduced to 20mg, 14mg, 10mg, 8mg, and 4mg qd according to the reduction criteria, and treatment will be discontinued if unable to tolerate at 4mg qd. Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: Primary outcome(s): Disease control rate Study Design: Open-label, single-arm and single-center trial, no treatment control standard of care control, No, open(masking not used),

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 98667 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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