Advanced Solid TumorsPhase 1NCT00139620
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
A Phase 1 study testing Tarceva, erlotinib, OSI-774 in people with Advanced Solid Tumors, run by OSI Pharmaceuticals at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Tarceva, erlotinib, OSI-774
- How many people
- 39 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Aug 2005to 25 Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80010
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
Mayo Clinic
Rochester, Minnesota, 55905
Premiere Oncology
Santa Monica, California, 90404
United Kingdom1 site
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
About this study
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
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
- Being tested
- Tarceva, erlotinib, OSI-774
- Keywords
- advanced cancer, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarceva, erlotinib, OSI-774Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study start22 Aug 2005
- Primary completion25 Jun 2007
- Study completion25 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139620
- Sponsor's protocol ID
- OSI-774-104
- Other IDs
- 2006-002363-59
- Status last verified
- Jun 2015
- First submitted
- 25 Aug 2005
- Last updated
- 8 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00139620
- Acronym / sponsor ID
- OSI-774-104
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced cancer, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2005 (actual)
- Primary completion
- 25 Jun 2007 (actual)
- Study completion
- 25 Jun 2007 (actual)
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarceva, erlotinib, OSI-774 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarceva, erlotinib, OSI-774 in people with Advanced Solid Tumors, run by OSI Pharmaceuticals at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.