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NCT00110357 · ClinicalTrials.gov registry record · Phase 1
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00110357: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT00110357 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110357, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.
Primary Outcome
MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)
Interventions
- DRUG Cetuximab + Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00110357 record still lists
NCT00110357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Cetuximab + Irinotecan is the first listed.
NCT00110357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00110357 about?
NCT00110357 is a clinical study titled "Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors". The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.
What is the current status of trial NCT00110357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2005-08. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00110357?
The interventions under investigation include: Cetuximab + Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00110357?
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 NCT00110357's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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