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NCT01332266 · ClinicalTrials.gov registry record · Phase 1
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT01332266: Completed Phase 1 study of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck, sponsored by Eisai.
NCT01332266 is a Phase 1 study of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck that has completed, run by Eisai. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332266, a Phase 1 study of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.
Primary Outcome
DLT:adverse events graded as NCI CTCAEv4.0 occurring less than or equal to(\<=)28 days after treatment.Events as: Non-hematological: 1)Grade greater than or equal to(\>=)3 peripheral neuropathy; 2)Grade 3 fatigue or 2 point decline in eastern cooperative oncology group performance status that persisted for greater than(\>)7 days; 3)Grade \>=3 nausea,vomiting despite optimal antiemetic treatment; 4)Any nonhematologic toxicity of Grade \>=3, with exceptions as alopecia,single laboratory values out
Conditions Studied
Interventions
- DRUG Cetuximab
- DRUG E7050
Study Locations (20)
Other
- - Busan
- - Seoul
- - Seoul
- - Seoul
- - Seoul
- - Dnipropetrovsk
- - Donetsk
- - Donetsk
- - Kharkiv
- - Kyiv
- - Sumy
Arizona
- - Tucson
Florida
- - Fort Myers
Massachusetts
- - Boston
Missouri
- - St Louis
Ohio
- - Toledo
Oklahoma
- - Oklahoma City
Tennessee
- - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2011-09-19 |
| Est. Completion | 2017-09-04 |
| Phase | Phase 1 |
What the finished NCT01332266 record still lists
NCT01332266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Cetuximab is the first listed.
NCT01332266 names 20 study sites across 10 states, led by Other, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01332266 about?
NCT01332266 is a clinical study titled "E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck". The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.
What is the current status of trial NCT01332266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2011-09-19. Estimated completion is 2017-09-04.
What conditions does trial NCT01332266 study?
This clinical trial studies the following conditions: Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT01332266?
The interventions under investigation include: Cetuximab (DRUG), E7050 (DRUG).
Who is sponsoring clinical trial NCT01332266?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01332266 being conducted?
This trial has 20 study locations across Arizona, Florida, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01332266's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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