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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 is a Phase 1 study that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 39 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00139620
The ClinicalTrials.gov registry entry for NCT00139620 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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, erlotinib, OSI-774 is the first listed.
NCT00139620 reports 0 study locations.
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.
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