CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
Lenvatinibdrug
Likely dose
Lenvatinib 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01111461
NCT01111461Phase 2Completed

An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 (Lenvatinib) in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy

Eisai Inc.·interventional·Posted Apr 27, 2010·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating Lenvatinib for Endometrial Cancer. Completed, enrolled 133 participants across 78 sites in 8 countries.

Detailed Summary

To assess the objective response rate (ORR: complete response + partial response \[CR+ PR\]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Hungary, Poland, Romania, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2010
Enrollment StartMar 1, 2010
Primary CompletionMay 1, 2012
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.2 years ago

Interventions

Lenvatinibdrug

Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity.