Non Small Cell Lung CancerPhase 2NCT00743938
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
A Phase 2 study testing BMS-690514 and Erlotinib in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 30 sites in 8 countries.
Trial summary
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- BMS-690514 and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 2
- 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
- ECOG PS of 0 or 1
- Histologically confirmed NSCLC
- Adequate amount of tumor (archived or fresh) for biomarker evaluation
- Received one to two regimens of chemotherapy (with at least one platinum-containing)
- Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
- Stable control of blood pressure on agents other than calcium channel blockers
- Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
- Must be able to swallow pills and take the medications at the same time every day on an empty stomach
Who cannot join
- ECOG PS 2 or greater
- Women unwilling to avoid pregnancy or use adequate contraception
- Symptomatic brain metastases
- Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
- History of hemoptysis greater than 10 mL/day
- Significant cardiovascular disease
Show all 10Show fewer
- Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
- History of use of other TKIs
- Uncontrolled hypertension
- HIV+
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States9 sites
Mass General Hospital
Boston, Massachusetts, 02114
Henry Ford Hospital
Detroit, Michigan, 48202-2689
Hema/Oncology Assoc. Of Nepa
Dunmore, Pennsylvania, 18512
Cancer Center Of The Carolinas
Greenville, South Carolina, 29605
Yale University School Of Medicine
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Hematology Oncology, P.C.
Stamford, Connecticut, 06902-3628
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, 27103
Argentina5 sites
Local Institution
Bahía Blanca, Buenos Aires
Local Institution
Buenos Aires, Buenos Aires
Local Institution
Córdoba, Córdoba Province, X5000AAI
Local Institution
La Plata, Buenos Aires, 1900
Local Institution
La Rioja, La Rioja Province, 5300
France5 sites
Local Institution
Lyon, 69373
Local Institution
Marseille, 13915
Local Institution
Strasbourg, 67000
Local Institution
Toulouse, 31052
Local Institution
Villejuif, 94800
South Korea3 sites
Local Institution
Gyeonggi-do, 410-769
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Spain3 sites
Local Institution
Barcelona, 08035
Local Institution
Madrid, 28046
Local Institution
Vizcaya, 48903
Canada2 sites
Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- BMS-690514, Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-690514Drug
Also called panHER
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
ErlotinibDrug
Also called Tarceva
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: BMS-690514 |
| B2 | Active comparator | Not described Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Measured: CT/MRI at baseline and every 6 weeks for 36 weeks
Secondary outcomes (6)
To compare the overall survival between BMS-690514 and erlotinib
Measured: 15 months
To estimate the overall response rate of BMS-690514 or erlotinib
Measured: 15 months
To estimate the tumor size change and PFS rate at 6 weeks
Measured: 6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib
Measured: 15 months
To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib
Measured: 15 months
To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients
Measured: Days 1,8,15, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743938
- Sponsor's protocol ID
- CA187-017
- Other IDs
- EUDRACT #: 2008-004691-44
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
- ClinicalTrials.gov ID
- NCT00743938
- Acronym / sponsor ID
- CA187-017
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Aug 2008 (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.
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: BMS-690514 |
| B2 | Active comparator | Drug: Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ECOG PS of 0 or 1
- Histologically confirmed NSCLC
- Adequate amount of tumor (archived or fresh) for biomarker evaluation
- Received one to two regimens of chemotherapy (with at least one platinum-containing)
- Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
Key exclusion criteria (10 listed)
- ECOG PS 2 or greater
- Women unwilling to avoid pregnancy or use adequate contraception
- Symptomatic brain metastases
- Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
- History of hemoptysis greater than 10 mL/day
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 |
|---|---|---|
| BMS-690514Also: panHERTablets, Oral, 200 mg, once daily, Until disease progression or toxicity | Drug | A1 |
| ErlotinibAlso: TarcevaCapsules, Oral, 150 mg, once daily, Until disease progression or toxicity | Drug | B2 |
Primary outcome
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Time frame: CT/MRI at baseline and every 6 weeks for 36 weeks
6 secondary outcomes
To compare the overall survival between BMS-690514 and erlotinib
Time frame: 15 months
To estimate the overall response rate of BMS-690514 or erlotinib
Time frame: 15 months
To estimate the tumor size change and PFS rate at 6 weeks
Time frame: 6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib
Time frame: 15 months
To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib
Time frame: 15 months
To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients
Time frame: Days 1,8,15, 29
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 12 Oct 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-690514 and Erlotinib in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 30 sites in 8 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 8 inclusion and 10 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Argentina, France, South Korea, Spain and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 compare the progression-free survival of patients on BMS-690514 with those on erlotinib (time frame: CT/MRI at baseline and every 6 weeks for 36 weeks). 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 12 Oct 2015.