NCT00121719

An Open Label Dose Escalation Study Of E7080

An Open Label Phase I Dose Escalation Study Of E7080

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.

Detailed description

This is an open-label, non-randomized, dose escalation study. Patients will be treated with lenvatinib once daily. Each four-week treatment period will be considered to be one treatment cycle. The selection of subsequent dose levels will be performed according to an accelerated design: Although initially 3 patients per dose level will be entered, the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity greater than grade 1 (except alopecia, lymphopenia and anemia).

Conditions

• Solid Tumor or Lymphoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib tablets taken orally, once daily.

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-06-19
• Completion: 2019-03-01
• First posted: 2005-07-21
• Last updated: 2023-06-22
• Results posted: 2016-05-27

Locations

2 sites across 2 countries: Netherlands, United Kingdom