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NCT01836029 · ClinicalTrials.gov registry record · Phase 2

Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study of Carcinoma, Squamous Cell of Head and Neck, sponsored by Celgene.

Completed
Registry status
Phase 2
Development phase
195
Enrollment target
20
Study locations

NCT01836029 is a Phase 2 study of Carcinoma, Squamous Cell of Head and Neck that has completed, run by Celgene. The registered enrollment target is 195 participants, roughly in line with the 205-participant average among 5 other Carcinoma, Squamous Cell of Head and Neck trials with a reported enrollment target. The trial reports 20 study locations across 12 states.

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The verdict

NCT01836029, a Phase 2 study of Carcinoma, Squamous Cell of Head and Neck, has completed, sponsored by Celgene.

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

Study Summary

The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.

Conditions Studied

Carcinoma, Squamous Cell of Head and Neck

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG 5-fluorouracil
  • DRUG VTX-2337

Study Locations (20)

California

  • Tower Hematology Oncology Medical Group - Beverly Hills
  • California Cancer Associates for Research and Excellence (CCARE) - Escondido
  • University of California San Diego Moores Cancer Center - La Jolla
  • University of California Norris Comprehensive Cancer Center - Los Angeles

Colorado

  • University of Colorado Cancer Center - Aurora
  • VA Eastern Colorado Healthcare System - Denver

Georgia

  • Northeast Georgia Cancer Care, LLC - Athens
  • Winship Cancer Institute - Atlanta

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago
  • Carle Cancer Center - Urbana

Louisiana

  • Crescent City Research Consortium, LLC - Marrero
  • Robert W. Veith, MD, LLC - Metairie

Maryland

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins - Baltimore
  • Walter Reed National Military Medical Center - Bethesda

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Delaware

  • Helen F. Graham Cancer Center - Newark

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2013-10-14
Est. Completion 2016-09-19
Phase Phase 2

Sponsor

Celgene

308 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01836029

The ClinicalTrials.gov registry entry for NCT01836029 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 205-participant average among 5 other Carcinoma, Squamous Cell of Head and Neck trials with a reported enrollment target. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoma, Squamous Cell of Head and Neck appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT01836029 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Colorado, Georgia.

Frequently Asked Questions

What is clinical trial NCT01836029 about?

NCT01836029 is a clinical study titled "Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetux...

What is the current status of trial NCT01836029?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2013-10-14. Estimated completion is 2016-09-19.

What conditions does trial NCT01836029 study?

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

What interventions are being tested in trial NCT01836029?

The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Cisplatin (DRUG), 5-fluorouracil (DRUG), VTX-2337 (DRUG).

Who is sponsoring clinical trial NCT01836029?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01836029 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Delaware, Florida. 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.