Clinical Trial: Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open-Label, Multicenter Phase 2 Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy

Brief Summary: This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: Objective response rate (ORR) [ Time Frame: At least 28 days after first dose of study drug ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival (PFS) [ Time Frame: From the date of first dose of study drug to the date of first documentation of disease progression or date of death from any cause, whichever occurs first, or up to approximately 3 years ]
  • Overall survival (OS) [ Time Frame: From the date of first dose of study drug to the date of death from any cause, or up to approximately 3 years ]
  • Disease control rate (DCR) [ Time Frame: Cycle 2 Day 8 ]
    DCR is defined as the percentage of participants with complete response (CR) + partial response (PR) + stable disease (SD).
  • Clinical benefit rate (CBR) [ Time Frame: From the date of first dose of study drug to the date of the first documentation of disease progression or death from any cause, whichever occurs first, or up to approximately 3 years ]
    CBR is defined as the percentage of participants with CR + PR + durable SD.
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From signing of informed consent form to 30 days after investigator decides discontinuation of this study or 30 days after last dose or off-treatment visit, whichever comes later, or up to approximately 3 years ]
  • Blood concentration [ Time Frame: Cycle 1 Day 1, Day 8, and Day 15; Cycle 2 Day 1 ]


Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: October 16, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: November 8, 2016
Last Verified: November 2016