At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 95 enrolled

Drug / intervention

E7050 +1 moredrug

Likely dose

E7050 400 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/NCT01332266

NCT01332266Phase 2Completed

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An Open-Label, Multicenter, Randomized, Phase 1b/2 Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

Eisai Inc.·interventional·Posted Apr 11, 2011·Updated Jan 3, 2022

In Brief

A Phase 2 clinical trial evaluating E7050 and Cetuximab for Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 95 participants across 23 sites in 4 countries.

Detailed Summary

The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPlatinum-Resistant Squamous Cell Carcinoma of the Head and Neck

CountriesSouth Korea, Ukraine, United Kingdom, United States

CollaboratorsPharmaBio Development Inc.

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedApr 2011

Enrollment StartSep 2011

Primary CompletionJan 2016

Study CompletionSep 2017

TodayJul 2026

First PostedApr 11, 2011

Enrollment StartSep 19, 2011

Primary CompletionJan 31, 2016

Study CompletionSep 4, 2017

TodayJul 2, 2026

Enrollment to primary: 4.4 yearsPosted 15.2 years ago

Interventions

E7050drug

E7050 given orally at 200, 300, or 400 mg once daily.

Cetuximabdrug

Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.