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

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tragara Pharmaceuticals, Inc.
• Treatments: Capecitabine; Lapatinib

Criteria

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