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NCT01081041 · ClinicalTrials.gov registry record · Phase 2
A Study in Head and Neck Cancer
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT01081041: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01081041 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081041, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
This study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs \[cisplatin or carboplatin plus 5-fluorouracil (5-FU)\] administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed. In the second part of this study, 200 participants will be randomized in 2 arms: * 100 participants will receive commercial cetuximab manufactured by ImClone (Group A) * 100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B). All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.
Primary Outcome
September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while pa
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01081041 record still lists
NCT01081041 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01081041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081041 about?
NCT01081041 is a clinical study titled "A Study in Head and Neck Cancer". This study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs \[cisplatin or carboplatin plus 5-fluorouracil (5-FU)\] administered every 3 weeks. After 18 weeks, participan...
What is the current status of trial NCT01081041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2010-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01081041?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Cetuximab (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT01081041?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01081041's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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