Status:
COMPLETED
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2007
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00139620
Start Date
August 22 2005
End Date
June 25 2007
Last Update
February 8 2018
Active Locations (5)
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1
Premiere Oncology
Santa Monica, California, United States, 90404
2
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232