APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00657137
- Lead Sponsor
- Tragara Pharmaceuticals, Inc.
- Brief Summary
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 12
- Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
- 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%
- Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A apricoxib + lapatinib + capecitabine apricoxib + lapatinib + capecitabine B placebo + lapatinib + capecitabine placebo + lapatinib + capecitabine
- Primary Outcome Measures
Name Time Method To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression. Time to disease progression
- Secondary Outcome Measures
Name Time Method Progression-free survival and safety/tolerability Time to disease progression
Trial Locations
- Locations (44)
UCLA
🇺🇸Los Angeles, California, United States
Eastern Regional Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Jabboury Foundation for Cancer Research Inc
🇺🇸Houston, Texas, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, 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
Cancer Care Associates Medical Group Inc
🇺🇸Redondo Beach, California, United States
Olive View- UCLA Medical Center
🇺🇸Olive View, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Hematology Oncology Associates
🇺🇸Lake Worth, Florida, United States
Front Range Cancer Specialists
🇺🇸Ft. Collins, Colorado, United States
Warren Billhartz Cancer Center
🇺🇸Maryville, Illinois, United States
Suburban Hematology-Oncology Associates
🇺🇸Lawrenceville, Georgia, United States
Medical Consultants PC
🇺🇸Muncie, Indiana, United States
Mid-Illinois Hematology Oncology Associates
🇺🇸Normal, Illinois, 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
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Associates in Hematology-Oncology PC
🇺🇸Upland, Pennsylvania, United States
Baptist Regional Cancer Center
🇺🇸Knoxville, Tennessee, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Fletcher Allen Healthcare Inc.
🇺🇸Burlington, Vermont, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
MD Anderson Cancer Center in Orlando
🇺🇸Orlando, Florida, United States
SJMH Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Charleston Oncology Hematology Associates
🇺🇸Charleston, South Carolina, United States
Community Cancer Center at Rutland Regional Medical Center
🇺🇸Rutland, Vermont, United States