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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 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 187 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01081041
The ClinicalTrials.gov registry entry for NCT01081041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01081041 reports 0 study locations.
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.
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