NCT03477175

Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials

An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety of Lenvatinib Monotherapy or Lenvatinib Combination Regimen or Comparator Treatment Arm to Cancer Patients in Eisai Sponsored Lenvatinib Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.

Detailed description

This is an open-label extension study to roll-over eligible participants from Eisai-sponsored lenvatinib studies. The participants may roll-over no sooner than the primary completion dates in their parent study or after all study data for the primary outcome measure have been collected for the parent study. The parent study is defined as the Eisai-sponsored lenvatinib clinical study in which the participant was receiving lenvatinib either as monotherapy or as combination therapy or was receiving any other comparator therapy. The participant can be enrolled in the current study for the purpose of long-term safety data collection if all the selection criteria for the current study are met. The intention is that the participant will not be without study drug during the transition from the parent study to the rollover study.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	E7080	Oral Administration.
DRUG	Comparator Drug	Per parent study.
DRUG	Comparator Drug: Sorafenib	Per parent study.

Timeline

• Start date: 2018-08-16
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2018-03-26
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

28 sites across 11 countries: United States, Australia, Belgium, China, Germany, Italy, Netherlands, Poland, Romania, South Korea, Thailand

Regulatory

• FDA-regulated drug study