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Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

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Trial Profile

Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Jun 2022

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At a glance

  • Drugs Lenvatinib (Primary)
  • Indications Liver cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Study 202
  • Sponsors Eisai Co Ltd

Most Recent Events

  • 07 Jun 2022 Results of post-hoc analysis of two studies ( Study 202: NCT00946153; REFLECT: NCT01761266) assessing efficacy and safety in patients with lower and higher bodyweights, published in the Hepatology Research.
  • 08 Jun 2021 Results of ad hoc analysis comparing compare safety and efficacy of lenvatinib based on patients bodyweight (less than 60 kg versus greater than equal to 60 kg) in Study 202 (n=46; all Asian, 43 Japanese; lenvatinib 12 mg/d irrespective of bodyweight) and in Japanese patients in REFLECT (n=81; Japanese pts; dose adjusted by bodyweight), presented at the 57th Annual Meeting of the American Society of Clinical Oncology.
  • 31 May 2017 Results (n= 452) assessing optimal lenvatinib dose based on population PK and exposure-response analysis using using pooled data from NCT00946153, NCT00121719, NCT00121680, NCT00280397, NCT01268293 and other 8 phase 1 studies in healthy adults, published in the Journal of Clinical Pharmacology

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