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NCT01166542 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
A Phase 3 study of Carcinoma, Squamous Cell of the Head and Neck, sponsored by Oncolytics Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
- 20
- Study locations
NCT01166542: Completed Phase 3 study of Carcinoma, Squamous Cell of the Head and Neck, sponsored by Oncolytics Biotech.
NCT01166542 is a Phase 3 study of Carcinoma, Squamous Cell of the Head and Neck that has completed, run by Oncolytics Biotech. The registered enrollment target is 167 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166542, a Phase 3 study of Carcinoma, Squamous Cell of the Head and Neck, has completed, sponsored by Oncolytics Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Paclitaxel
- BIOLOGICAL REOLYSIN
Study Locations (20)
California
- Providence Health and Services - Burbank
- Wilshire Oncology Medical Group - Corona
- BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates - Orange
Texas
- Texas Oncology- Sammons Cancer Center - Dallas
- Cancer Therapy and Research Center at UTHSCSA - San Antonio
- Texas Oncology - Tyler - Tyler
Ohio
- Case Comprehensive Cancer Center, University Hospitals Case Medical Center - Cleveland
- Mercy Cancer Center - Toledo
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Arizona Oncology Associates - Tucson
Colorado
- Rocky Mountain Cancer Centers - Denver
Florida
- Pasco Hernando Oncology Associates, PA - New Port Richey
Georgia
- Emory University - Winship Cancer Institute - Altanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01166542 record still lists
NCT01166542 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Carcinoma, Squamous Cell of the Head and Neck appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT01166542 names 20 study sites across 15 states, led by California, Texas, Ohio.
Frequently Asked Questions
What is clinical trial NCT01166542 about?
NCT01166542 is a clinical study titled "Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers". The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent ...
What is the current status of trial NCT01166542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2010-06. Estimated completion is 2014-05.
What conditions does trial NCT01166542 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell of the Head and Neck.
What interventions are being tested in trial NCT01166542?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Paclitaxel (DRUG), REOLYSIN (BIOLOGICAL).
Who is sponsoring clinical trial NCT01166542?
This trial is sponsored by Oncolytics Biotech, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01166542 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01166542's enrollment target sits among peer trials
167 1463rd of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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