APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
NCT ID: NCT00657137
Last Updated: 2012-03-15
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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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2008-04-30
2009-09-30
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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A
apricoxib + lapatinib + capecitabine
apricoxib + lapatinib + capecitabine
apricoxib: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
B
placebo + lapatinib + capecitabine
placebo + lapatinib + capecitabine
placebo: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
Interventions
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apricoxib + lapatinib + capecitabine
apricoxib: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
placebo + lapatinib + capecitabine
placebo: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
Eligibility Criteria
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Inclusion Criteria
* Have progressed after treatment with chemotherapy including a taxane and trastuzumab
* Must have measurable disease by RECIST
* ECOG PS of 0,1, or 2
* MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
Exclusion Criteria
* Evidence of New York Heart Association class III or greater cardiac disease
* History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
* History of congenital QT prolongation
* Concurrent severe or uncontrolled medical disease
* Symptomatic central nervous system metastases
* Pregnant or nursing women
* Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs
* Severe renal insufficiency
* History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers
* Prior treatment with capecitabine
* Patients on anti-arrhythmic treatment
* Prior lapatinib therapy
18 Years
FEMALE
No
Sponsors
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Tragara Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sara Zaknoen, M.D.
Role: STUDY_DIRECTOR
Tragara Pharmaceuticals, Inc.
Locations
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Arizona Clinical Research Center
Tucson, Arizona, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Bay Area Cancer Research Group, LLC
Concord, California, United States
St. Jude Heritage Healthcare
Fullerton, California, United States
Wilshire Oncology Medical Group Inc
Inland Valleys/Pomona, California, United States
UCLA
Los Angeles, California, United States
Olive View- UCLA Medical Center
Olive View, California, United States
Cancer Care Associates Medical Group Inc
Redondo Beach, California, United States
North America Research Institute
San Dimas, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
MD Anderson Cancer Center in Orlando
Orlando, Florida, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, United States
Warren Billhartz Cancer Center
Maryville, Illinois, United States
Mid-Illinois Hematology Oncology Associates
Normal, Illinois, United States
Medical Consultants PC
Muncie, Indiana, United States
SJMH Cancer Center
Ann Arbor, Michigan, United States
Genesys Hurley Cancer Center Institute
Flint, Michigan, United States
Foote Health System
Jackson County, Michigan, United States
Bresline Cancer Center at Michigan State University
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Hospital
Port Huron, Michigan, United States
St. Mary's of Michigan
Saginaw, Michigan, United States
St. Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Warren Hospital
Phillipsburg, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Samaritan Hematology and Oncology Consulting
Corvallis, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Associates in Hematology-Oncology PC
Upland, Pennsylvania, United States
Charleston Oncology Hematology Associates
Charleston, South Carolina, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Jabboury Foundation for Cancer Research Inc
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Fletcher Allen Healthcare Inc.
Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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APRiCOT-B
Identifier Type: -
Identifier Source: secondary_id
TP2001-202
Identifier Type: -
Identifier Source: org_study_id
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