NSCLCPhase 1NCT00294736
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
A Phase 1 study testing Tarceva in people with NSCLC, run by OSI Pharmaceuticals at 9 sites in 2 countries.
Trial summary
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Tarceva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Nov 2005to Sep 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 or cytologically confirmed diagnosis of stage IIIB/IV NSCLC;
- Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease;
- Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity;
- A current cigarette smoker (minimum of 10 cigarettes per day for >= 1 year and have a positive test for cotinine) despite advice and support to quit;
- Age >= 18 years;
- ECOG PS 0-1 and predicted life expectancy >= 12 weeks;
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- Previous surgery is permitted provided that wound healing has occurred prior to registration;
- Adequate hematopoietic, hepatic and renal function defined as follows: ANC >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, bilirubin <= 1.5 x ULN, ALT <= 2.5 x ULN (or 5 x ULN in case of liver metastases), creatinine <= 1.5 x ULN;
- No prior treatment with Tarceva or gefitinib (or other drug with significant activity against EGFR (eg, cetuximab and/or ZD6474));
- Patients with reproductive potential must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test within 14 days prior to registration;
- Accessible for repeat dosing and follow-up.
Who cannot join
- Any concurrent anticancer cytostatic or cytotoxic chemotherapy;
- Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco;
- Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded;
- Significant history of cardiac disease unless the disease is well-controlled;
- Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study;
- History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements; of the study or to provide informed consent.
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- Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption;
- Clinically significant ophthalmologic abnormalities;
- Pregnant or breast-feeding females. Males or females not practicing effective birth control;
- Symptomatic brain metastases which are not stable, require steroids, or that have required radiation within the last 28 days;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug;
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom7 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Ninewells Hospital
Dundee, DD1 9SY
University of Edinburgh,Division of Oncology,
Edinburgh, Scotland, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, NE7 7DH
Department of Oncology
Sheffield, S10 2SJ
Royal Marsden Hospital
Sutton, SM2 5PT
United States2 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke.
Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.
In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
- Conditions
- NSCLC
- Being tested
- Tarceva
- Keywords
- lung cancer, erlotinib, NSCLC, smokers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarcevaDrug
Dose Escalation: 150-350+ mg/day
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A (Tarceva MTD established in Part I) Receives: Drug: Tarceva |
| Arm B | Experimental | Arm B (150 mg Tarceva daily). Receives: Drug: Tarceva |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
Measured: 2 years
Secondary outcomes (1)
To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, OSI Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294736
- Sponsor's protocol ID
- OSI-774-107
- Other IDs
- 2005-003883-46, 2005
- Status last verified
- Aug 2012
- First submitted
- 17 Feb 2006
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT00294736
- Acronym / sponsor ID
- OSI-774-107
- Conditions
- NSCLC
- Keywords
- lung cancer, erlotinib, NSCLC, smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Feb 2006 (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, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke.
Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.
In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: TarcevaArm A (Tarceva MTD established in Part I) |
| Arm B | Experimental | Drug: TarcevaArm B (150 mg Tarceva daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC;
- Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease;
- Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity;
- A current cigarette smoker (minimum of 10 cigarettes per day for >= 1 year and have a positive test for cotinine) despite advice and support to quit;
- Age >= 18 years;
Key exclusion criteria (11 listed)
- Any concurrent anticancer cytostatic or cytotoxic chemotherapy;
- Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco;
- Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded;
- Significant history of cardiac disease unless the disease is well-controlled;
- Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study;
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 |
|---|---|---|
| TarcevaDose Escalation: 150-350+ mg/day | Drug | Arm A, Arm B |
Primary outcome
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
Time frame: 2 years
1 secondary outcome
To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.
Time frame: 2 years
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 Aug 2012.
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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.
Medical Monitor study director
OSI Pharmaceuticals
9 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 in people with NSCLC, run by OSI Pharmaceuticals at 9 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 11 inclusion and 11 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, United States. 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.
What does the primary outcome measure?
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 Aug 2012.