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NCT01696955 · ClinicalTrials.gov registry record · Phase 2

Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery

A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
81
Enrollment target
20
Study locations

NCT01696955 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 81 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT01696955, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
81 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Carcinoma

Interventions

  • BIOLOGICAL Cetuximab
  • OTHER Laboratory Biomarker Analysis
  • DRUG Tivantinib

Study Locations (20)

Illinois

  • Northwestern University - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago
  • Decatur Memorial Hospital - Decatur
  • NorthShore University HealthSystem-Evanston Hospital - Evanston
  • Ingalls Memorial Hospital - Harvey
  • Illinois CancerCare-Peoria - Peoria
  • Southern Illinois University School of Medicine - Springfield

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • City of Hope South Pasadena - South Pasadena

Indiana

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
  • Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor
  • Wayne State University/Karmanos Cancer Institute - Detroit

Minnesota

  • Mayo Clinic - Rochester
  • Metro Minnesota Community Oncology Research Consortium - Saint Louis Park

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Iowa

  • University of Iowa/Holden Comprehensive Cancer Center - Iowa City

Maryland

  • University of Maryland/Greenebaum Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2012-08-20
Est. Completion 2017-05-05
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT01696955

The ClinicalTrials.gov registry entry for NCT01696955 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (31% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.

NCT01696955 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Illinois, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT01696955 about?

NCT01696955 is a clinical study titled "Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery". 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, ma...

What is the current status of trial NCT01696955?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2012-08-20. Estimated completion is 2017-05-05.

What conditions does trial NCT01696955 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma.

What interventions are being tested in trial NCT01696955?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Tivantinib (DRUG).

Who is sponsoring clinical trial NCT01696955?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01696955 being conducted?

This trial has 20 study locations across Arizona, California, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.