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NCT00139620 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
A Phase 1 study, sponsored by OSI Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT00139620: Completed Phase 1 study, sponsored by OSI Pharmaceuticals.
NCT00139620 is a Phase 1 study that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00139620, a Phase 1 study, has completed, sponsored by OSI Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by 96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the maintenance phase of the study and continue to receive erlotinib until disease progression or unacceptable toxicity.
Interventions
- DRUG Tarceva, erlotinib, OSI-774
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2005-08-22 |
| Est. Completion | 2007-06-25 |
| Phase | Phase 1 |
What the finished NCT00139620 record still lists
NCT00139620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Tarceva, erlotinib, OSI-774 is the first listed.
NCT00139620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00139620 about?
NCT00139620 is a clinical study titled "A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function". This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by 96 hours of plasma sampling for PK a...
What is the current status of trial NCT00139620?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2005-08-22. Estimated completion is 2007-06-25.
What interventions are being tested in trial NCT00139620?
The interventions under investigation include: Tarceva, erlotinib, OSI-774 (DRUG).
Who is sponsoring clinical trial NCT00139620?
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 NCT00139620's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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