APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00657137

Run by

Tragara Pharmaceuticals, Inc.

People needed

12

Starts

2008-04-01

Expected to finish

2009-09-01

Last updated by the study team

2012-03-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.