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NCT00895362 · ClinicalTrials.gov registry record · Phase 1
Erlotinib in Combination With Cetuximab
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00895362: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00895362 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00895362, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.
Primary Outcome
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any ot
Interventions
- DRUG Cetuximab
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00895362 record still lists
NCT00895362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00895362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00895362 about?
NCT00895362 is a clinical study titled "Erlotinib in Combination With Cetuximab". The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.
What is the current status of trial NCT00895362?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2009-04.
What interventions are being tested in trial NCT00895362?
The interventions under investigation include: Cetuximab (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00895362?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895362's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 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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