Status:
TERMINATED
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
Lead Sponsor:
Tragara Pharmaceuticals, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00657137
Start Date
April 1 2008
End Date
September 1 2009
Last Update
March 15 2012
Active Locations (44)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
3
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
4
Bay Area Cancer Research Group, LLC
Concord, California, United States