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

Part of paid clinical trials in Santa Monica, California.

Sponsor
OSI Pharmaceuticals
Study ID
NCT00139620
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 31, 2005
Start date
Aug 22, 2005
Status verified
Jun 2015
Primary completion
Jun 25, 2007
Completion
Jun 25, 2007

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Locations (4)

FacilityCityStateZIPSite coordinators
Premiere OncologySanta MonicaCalifornia90404-
University of Colorado Health Sciences CenterAuroraColorado80010-
Mayo ClinicRochesterMinnesota55905-
UPMC Cancer PavilionPittsburghPennsylvania15232-

Find similar trials in Santa Monica, CA

By research site
Premiere Oncology· Santa Monica, CAUniversity of Colorado Health Sciences Center· Aurora, COMayo Clinic· Rochester, MNUPMC Cancer Pavilion· Pittsburgh, PA

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