A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
No
Sara Zaknoen, M.D.
Study Director
Tragara Pharmaceuticals, Inc.
United States: Food and Drug Administration
TP2001-202
NCT00657137
April 2008
September 2009
Name | Location |
---|---|
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Warren Hospital | Phillipsburg, New Jersey 08865 |
Hematology Oncology Associates | Atlantis, Florida 33462 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Mercy Hospital | Port Huron, Michigan 48060 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Baptist Regional Cancer Center | Knoxville, Tennessee 37920 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
UCLA | Los Angeles, California 90095 |
Bay Area Cancer Research Group, LLC | Concord, California 94520 |
San Juan Oncology Associates | Farmington, New Mexico 87401 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Suburban Hematology-Oncology Associates | Lawrenceville, Georgia 30045 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Toledo | Toledo, Ohio 43614 |
The Methodist Hospital Research Institute | Houston, Texas 77030 |
Central Coast Medical Oncology Corporation | Santa Maria, California 93454 |
Wilshire Oncology Medical Group Inc | Laverne, California 91750 |
St. Jude Heritage Healthcare | Fullerton, California 92835 |
Olive View- UCLA Medical Center | Sylmar, California 91342 |
Cancer Care Associates Medical Group Inc | Redondo Beach, California |
North America Research Institute | San Dimas, California |
MD Anderson Cancer Center in Orlando | Orlando, Florida |
Warren Billhartz Cancer Center | Maryville, Illinois |
Mid-Illinois Hematology Oncology Associates | Normal, Illinois |
Medical Consultants PC | Muncie, Indiana |
SJMH Cancer Center | Ann Arbor, Michigan |
Genesys Hurley Cancer Center Institute | Flint, Michigan |
Foote Health System | Jackson County, Michigan |
Bresline Cancer Center at Michigan State University | Lansing, Michigan |
St. Mary's of Michigan | Saginaw, Michigan |
St. Francis Cancer Treatment Center | Grand Island, Nebraska |
Samaritan Hematology and Oncology Consulting | Corvallis, Oregon |
Eastern Regional Medical Center | Philadelphia, Pennsylvania |
Associates in Hematology-Oncology PC | Upland, Pennsylvania |
Charleston Oncology Hematology Associates | Charleston, South Carolina |
Jabboury Foundation for Cancer Research Inc | Houston, Texas |
Fletcher Allen Healthcare Inc. | Burlington, Vermont |