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Completed Phase 1 Interventional

A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function

ClinicalTrials.gov ID: NCT00139620

Public ClinicalTrials.gov record NCT00139620. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 6, 2026, 3:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00139620
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
OSI Pharmaceuticals
Industry
Enrollment
39 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 22, 2005 (Actual)
Primary completion
Jun 25, 2007 (Actual)
Completion
Jun 25, 2007 (Actual)
Last update posted
Feb 8, 2018

2005 – 2007

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Premiere Oncology Santa Monica California 90404 —
University of Colorado Health Sciences Center Aurora Colorado 80010 —
Mayo Clinic Rochester Minnesota 55905 —
UPMC Cancer Pavilion Pittsburgh Pennsylvania 15232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00139620, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 8, 2018 · Synced Oct 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00139620 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →