A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
NCT ID: NCT00743938
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2009-03-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A1
BMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
B2
Erlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Interventions
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BMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
Erlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
* History of use of other TKIs
* Uncontrolled hypertension
* HIV+
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Yale University School Of Medicine
New Haven, Connecticut, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
Mass General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Hema/Oncology Assoc. Of Nepa
Dunmore, Pennsylvania, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, United States
Local Institution
Bahía Blanca, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
La Plata, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
La Rioja, La Rioja Province, Argentina
Local Institution
Montreal, Quebec, Canada
Local Institution
Sherbrooke, Quebec, Canada
Local Institution
Lyon, , France
Local Institution
Marseille, , France
Local Institution
Strasbourg, , France
Local Institution
Toulouse, , France
Local Institution
Villejuif, , France
Local Institution
Otwock, , Poland
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Vizcaya, , Spain
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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EUDRACT #: 2008-004691-44
Identifier Type: -
Identifier Source: secondary_id
CA187-017
Identifier Type: -
Identifier Source: org_study_id
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