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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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Extracorporeal magnetic navigation system of capsule endoscopy

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

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Project description:Context: Glucocorticoids are frequently prescribed drugs with important side-effects such as glucose intolerance and tissue remodelling. Objective: The goal was to explore the molecular basis of the crosstalk between adipose tissue and skeletal muscle during short term glucocorticoid treatment. Design and Intervention: Healthy male subjects were assigned to a 4-d treatment with dexamethasone at 4mg/d. Main Outcome Measures: Primary outcome measures were gene expression profiling of adipose tissue and skeletal muscle. Urinary cortisol and metabolic biochemistry were also assessed. Dexamethasone was provided in 0.5 mg tablets as 4mg per day during 4 days to male healthy volunteers. Skeletal muscle and adipose tissue biopsies were obtained at the beginning and at the end of the protocol. The transcriptome analysis compared before vs. after the 4 days dexamethasone treatment using a dye swap design and whole genome 4x44k oligonucleotide arrays (Agilent Technologies).

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