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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: apricoxib + lapatinib + capecitabine; Drug: placebo + lapatinib + capecitabine

• Registration Number: NCT00657137
• Lead Sponsor: Tragara Pharmaceuticals, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-31
• Study Start: 2008-04
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	apricoxib + lapatinib + capecitabine	apricoxib + lapatinib + capecitabine
B	placebo + lapatinib + capecitabine	placebo + lapatinib + capecitabine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-free survival and safety/tolerability	Time to disease progression

Trial Locations

Locations (44)

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

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