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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors	Drug: Tarceva, erlotinib, OSI-774	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	August 22, 2005
Actual Primary Completion Date :	June 25, 2007
Actual Study Completion Date :	June 25, 2007

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is potentially responsive to erlotinib or for which no effective therapy is available,
• Cohort 1: Adequate hepatic function: bilirubin <= ULN, ALT (SGPT) and AST (SGOT) <= 1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System, ECOG Performance Status 0-2
• Life expectancy >= 12 weeks,
• Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation) has elapsed and patients have recovered from acute toxic effects of radiotherapy,
• Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have recovered from acute toxic effects of chemotherapy,
• Adequate hematopoietic and renal function: ANC >= 1.5 x 10^9/L, platelets >= 75 x 10^9/L, and creatinine <= 1.5 x ULN,

Exclusion Criteria:

• Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on study,
• Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,
• Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until Day 5,
• Encephalopathy >= grade 2,
• Significant history of cardiac disease unless well-controlled,
• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation,
• Concurrent anticancer therapy or any other investigational agents within 4 weeks of Day 1 and while on study,
• Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within the last 4 weeks,
• Gastro-intestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption.

Contacts and Locations

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Locations

United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

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Additional Information:

Link to results on Astellas Clinical Study Results website 

ClinicalTrials.gov Identifier:	NCT00139620 History of Changes
Other Study ID Numbers:	OSI-774-104; 2006-002363-59 ( EudraCT Number )
First Posted:	August 31, 2005
Last Update Posted:	February 8, 2018
Last Verified:	June 2015

Keywords provided by Astellas Pharma Inc:

advanced cancer, solid tumor

Additional relevant MeSH terms:

Erlotinib Hydrochloride; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action