CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Cetuximab +2 morebiological
Likely dose
Not stated in 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/NCT01696955
NCT01696955Phase 2Completed

A Randomized Phase II Trial of ARQ 197 (Tivantinib)/Cetuximab Versus Cetuximab in Patients With Recurrent/Metastatic Head and Neck Cancer

National Cancer Institute (NCI)·interventional·Posted Oct 2, 2012·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Laboratory Biomarker Analysis, and 1 other intervention for Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma. Completed, enrolled 81 participants across 24 sites.

Detailed Summary

This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartAug 20, 2012
Primary CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.8 years ago

Interventions

Cetuximabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Tivantinibdrug

Given PO