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NCT00585533 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00585533: Completed Phase 2 study, sponsored by University of Utah.
NCT00585533 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585533, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
Primary Outcome
Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
Interventions
- DRUG Erlotinib (Tarceva)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT00585533 record still lists
NCT00585533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Erlotinib (Tarceva) is the first listed.
NCT00585533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585533 about?
NCT00585533 is a clinical study titled "A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer". This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likel...
What is the current status of trial NCT00585533?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00585533?
The interventions under investigation include: Erlotinib (Tarceva) (DRUG).
Who is sponsoring clinical trial NCT00585533?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585533's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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