A Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer - Full Text View

Sponsored by:	Tragara Pharmaceuticals, Inc.
Information provided by:	Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00657137

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: apricoxib + lapatinib + capecitabine Drug: placebo + lapatinib + capecitabine	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Lapatinib Lapatinib Ditosylate Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Tragara Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 Frame: Time to disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival and safety/tolerability [ Time Frame: Time to disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental apricoxib + lapatinib + capecitabine	Drug: apricoxib + lapatinib + capecitabine apricoxib: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert
B: Placebo Comparator placebo + lapatinib + capecitabine	Drug: placebo + lapatinib + capecitabine placebo: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657137

Contacts

Contact: Karen Kuhn

kkuhn@ockham.com

Show 50 Study Locations

Sponsors and Collaborators

Tragara Pharmaceuticals, Inc.

Investigators

Study Director:

Sara Zaknoen, M.D.

Tragara Pharmaceuticals, Inc.

More Information

Responsible Party:	Tragara Pharmaceuticals, Inc. ( Sara Zaknoen, M.D. )
Study ID Numbers:	TP2001-202, APRiCOT-B
Study First Received:	March 31, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00657137
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tragara Pharmaceuticals, Inc.:

HER2/neu positive
locally advanced or metastatic

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Trastuzumab
Breast Neoplasms

Lapatinib
Taxane
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009