Breast Cancer Clinical Trial
— APRiCOT-BOfficial title:
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
| Verified date | March 2012 |
| Source | Tragara Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | September 2009 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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% Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | SJMH Cancer Center | Ann Arbor | Michigan |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California |
| United States | Fletcher Allen Healthcare Inc. | Burlington | Vermont |
| United States | Charleston Oncology Hematology Associates | Charleston | South Carolina |
| United States | Bay Area Cancer Research Group, LLC | Concord | California |
| United States | Samaritan Hematology and Oncology Consulting | Corvallis | Oregon |
| United States | San Juan Oncology Associates | Farmington | New Mexico |
| United States | Genesys Hurley Cancer Center Institute | Flint | Michigan |
| United States | Front Range Cancer Specialists | Ft. Collins | Colorado |
| United States | St. Jude Heritage Healthcare | Fullerton | California |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | St. Francis Cancer Treatment Center | Grand Island | Nebraska |
| United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
| United States | Jabboury Foundation for Cancer Research Inc | Houston | Texas |
| United States | The Methodist Hospital Research Institute | Houston | Texas |
| United States | Wilshire Oncology Medical Group Inc | Inland Valleys/Pomona | California |
| United States | Foote Health System | Jackson County | Michigan |
| United States | Baptist Regional Cancer Center | Knoxville | Tennessee |
| United States | Hematology Oncology Associates | Lake Worth | Florida |
| United States | Bresline Cancer Center at Michigan State University | Lansing | Michigan |
| United States | Suburban Hematology-Oncology Associates | Lawrenceville | Georgia |
| United States | St. Mary Mercy Hospital | Livonia | Michigan |
| United States | UCLA | Los Angeles | California |
| United States | Warren Billhartz Cancer Center | Maryville | Illinois |
| United States | Medical Consultants PC | Muncie | Indiana |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Mid-Illinois Hematology Oncology Associates | Normal | Illinois |
| United States | Olive View- UCLA Medical Center | Olive View | California |
| United States | MD Anderson Cancer Center in Orlando | Orlando | Florida |
| United States | Eastern Regional Medical Center | Philadelphia | Pennsylvania |
| United States | Warren Hospital | Phillipsburg | New Jersey |
| United States | Mercy Hospital | Port Huron | Michigan |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Cancer Care Associates Medical Group Inc | Redondo Beach | California |
| United States | Community Cancer Center at Rutland Regional Medical Center | Rutland | Vermont |
| United States | St. Mary's of Michigan | Saginaw | Michigan |
| United States | North America Research Institute | San Dimas | California |
| United States | Central Coast Medical Oncology Corporation | Santa Maria | California |
| United States | Flower Hospital Cancer Center | Sylvania | Ohio |
| United States | Madigan Army Medical Center | Tacoma | Washington |
| United States | University of Toledo | Toledo | Ohio |
| United States | Arizona Clinical Research Center | Tucson | Arizona |
| United States | Associates in Hematology-Oncology PC | Upland | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Tragara Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Progression-free survival and safety/tolerability | Time to disease progression |
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