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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Time to disease progression

Safety Issue:

No

Principal Investigator

Sara Zaknoen, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TP2001-202

NCT ID:

NCT00657137

Start Date:

April 2008

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • HER2/neu positive
  • locally advanced or metastatic
  • Breast Neoplasms

Name

Location

University of Texas Medical BranchGalveston, Texas  77555-1329
Madigan Army Medical CenterTacoma, Washington  98431-5048
Warren HospitalPhillipsburg, New Jersey  08865
Hematology Oncology AssociatesAtlantis, Florida  33462
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Mercy HospitalPort Huron, Michigan  48060
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
St. Mary Mercy HospitalLivonia, Michigan  48154
Flower Hospital Cancer CenterSylvania, Ohio  43560
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Community Cancer Center at Rutland Regional Medical CenterRutland, Vermont  05701
Arizona Clinical Research CenterTucson, Arizona  85712
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
Providence Portland Medical CenterPortland, Oregon  97213-3635
UCLALos Angeles, California  90095
Bay Area Cancer Research Group, LLCConcord, California  94520
San Juan Oncology AssociatesFarmington, New Mexico  87401
Peninsula Cancer InstituteNewport News, Virginia  23601
Suburban Hematology-Oncology AssociatesLawrenceville, Georgia  30045
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
University of ToledoToledo, Ohio  43614
The Methodist Hospital Research InstituteHouston, Texas  77030
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Wilshire Oncology Medical Group IncLaverne, California  91750
St. Jude Heritage HealthcareFullerton, California  92835
Olive View- UCLA Medical CenterSylmar, California  91342
Cancer Care Associates Medical Group IncRedondo Beach, California  
North America Research InstituteSan Dimas, California  
MD Anderson Cancer Center in OrlandoOrlando, Florida  
Warren Billhartz Cancer CenterMaryville, Illinois  
Mid-Illinois Hematology Oncology AssociatesNormal, Illinois  
Medical Consultants PCMuncie, Indiana  
SJMH Cancer CenterAnn Arbor, Michigan  
Genesys Hurley Cancer Center InstituteFlint, Michigan  
Foote Health SystemJackson County, Michigan  
Bresline Cancer Center at Michigan State UniversityLansing, Michigan  
St. Mary's of MichiganSaginaw, Michigan  
St. Francis Cancer Treatment CenterGrand Island, Nebraska  
Samaritan Hematology and Oncology ConsultingCorvallis, Oregon  
Eastern Regional Medical CenterPhiladelphia, Pennsylvania  
Associates in Hematology-Oncology PCUpland, Pennsylvania  
Charleston Oncology Hematology AssociatesCharleston, South Carolina  
Jabboury Foundation for Cancer Research IncHouston, Texas  
Fletcher Allen Healthcare Inc.Burlington, Vermont