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NCT00294736 · ClinicalTrials.gov registry record · Phase 1
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
A Phase 1 study, sponsored by OSI Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00294736: Completed Phase 1 study, sponsored by OSI Pharmaceuticals.
NCT00294736 is a Phase 1 study that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 57 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
NCT00294736, a Phase 1 study, has completed, sponsored by OSI Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
Interventions
- DRUG Tarceva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2005-11 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
What the finished NCT00294736 record still lists
NCT00294736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 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 1 intervention - of which Tarceva is the first listed.
NCT00294736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00294736 about?
NCT00294736 is a clinical study titled "A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens". This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. In Part II, patients will be randomized 1:1 to two treatment groups:...
What is the current status of trial NCT00294736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2005-11. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00294736?
The interventions under investigation include: Tarceva (DRUG).
Who is sponsoring clinical trial NCT00294736?
This trial is sponsored by OSI Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00294736's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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