Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT01836029 · View on ClinicalTrials.gov ↗

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.

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

73 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01836029 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01836029?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial