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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 is a Phase 1 study that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 57 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00294736
The ClinicalTrials.gov registry entry for NCT00294736 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OSI Pharmaceuticals, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tarceva is the first listed.
NCT00294736 reports 0 study locations.
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.
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