A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
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| ClinicalTrials.gov Identifier: NCT00139620 |
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Recruitment Status :
Completed
First Posted : August 31, 2005
Last Update Posted : February 8, 2018
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Sponsor:
OSI Pharmaceuticals
Information provided by:
Astellas Pharma Inc
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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 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00139620 History of Changes |
| Other Study ID Numbers: |
OSI-774-104 2006-002363-59 ( EudraCT Number ) |
| First Posted: | August 31, 2005 Key Record Dates |
| Last Update Posted: | February 8, 2018 |
| Last Verified: | June 2015 |
Keywords provided by Astellas Pharma Inc:
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advanced cancer, solid tumor |
Additional relevant MeSH terms:
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Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |