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

NCT ID: NCT00139620

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-22
• Study Completion Date: 2007-06-25

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Tarceva, erlotinib, OSI-774

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Premiere Oncology

Santa Monica, California, United States

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Mayo Clinic

Rochester, Minnesota, United States

UPMC Cancer Pavilion

Pittsburgh, Pennsylvania, United States

The Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Countries

United States; United Kingdom

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=55

Link to results on Astellas Clinical Study Results website

Other Identifiers

2006-002363-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSI-774-104

Identifier Type: -

Identifier Source: org_study_id