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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: Completed Phase 2 study of Carcinoma, Squamous Cell of Head and Neck, sponsored by Celgene.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2013-10-14 |
| Est. Completion | 2016-09-19 |
| Phase | Phase 2 |
What the finished NCT01836029 record still lists
NCT01836029 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, 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 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 names 20 study sites across 12 states, led by 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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