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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139620
• Other study ID #: OSI-774-104
• Secondary ID: 2006-002363-59
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2005
• Last updated: February 6, 2018
• Start date: August 22, 2005
• Est. completion date: June 25, 2007

Study information

• Verified date: June 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 25, 2007
• Est. primary completion date: June 25, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• Tarceva, erlotinib, OSI-774

Locations

Country	Name	City	State
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	UPMC Cancer Pavilion	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

External Links

•   Link to results on Astellas Clinical Study Results website