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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00139620
First received: August 25, 2005
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: Tarceva, erlotinib, OSI-774
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Enrollment: 39
Study Start Date: May 2005
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139620

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

No publications provided

ClinicalTrials.gov Identifier: NCT00139620     History of Changes
Other Study ID Numbers: OSI-774-104, 2006-002363-59
Study First Received: August 25, 2005
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
advanced cancer, solid tumor

Additional relevant MeSH terms:
Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014