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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Tragara Pharmaceuticals, Inc.
Study ID
NCT00657137
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apricoxib + lapatinib + capecitabine — DRUG
    apricoxib: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert
  • placebo + lapatinib + capecitabine — DRUG
    placebo: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert

Study Details

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.

Key Dates

Start date
Apr 30, 2008
Status verified
Mar 2012
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    apricoxib + lapatinib + capecitabine
  • Placebo Comparator: B
    placebo + lapatinib + capecitabine

Primary 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. [ Time Frame: Time to disease progression ]

Locations (44)

FacilityCityStateZIPSite coordinators
Arizona Clinical Research CenterTucsonArizona--
Comprehensive Blood and Cancer CenterBakersfieldCalifornia--
Alta Bates Summit Comprehensive Cancer CenterBerkeleyCalifornia--
Bay Area Cancer Research Group, LLCConcordCalifornia--
St. Jude Heritage HealthcareFullertonCalifornia--
Wilshire Oncology Medical Group IncInland Valleys/PomonaCalifornia--
UCLALos AngelesCalifornia--
Olive View- UCLA Medical CenterOlive ViewCalifornia--
Cancer Care Associates Medical Group IncRedondo BeachCalifornia--
North America Research InstituteSan DimasCalifornia--
Central Coast Medical Oncology CorporationSanta MariaCalifornia--
Front Range Cancer SpecialistsFort CollinsColorado--
Hematology Oncology AssociatesLake WorthFlorida--
MD Anderson Cancer Center in OrlandoOrlandoFlorida--
Suburban Hematology-Oncology AssociatesLawrencevilleGeorgia--
Warren Billhartz Cancer CenterMaryvilleIllinois--
Mid-Illinois Hematology Oncology AssociatesNormalIllinois--
Medical Consultants PCMuncieIndiana--
SJMH Cancer CenterAnn ArborMichigan--
Genesys Hurley Cancer Center InstituteFlintMichigan--
Foote Health SystemJackson CountyMichigan--
Bresline Cancer Center at Michigan State UniversityLansingMichigan--
St. Mary Mercy HospitalLivoniaMichigan--
Mercy HospitalPort HuronMichigan--
St. Mary's of MichiganSaginawMichigan--
St. Francis Cancer Treatment CenterGrand IslandNebraska--
Warren HospitalPhillipsburgNew Jersey--
San Juan Oncology AssociatesFarmingtonNew Mexico--
Flower Hospital Cancer CenterSylvaniaOhio--
University of ToledoToledoOhio--
Samaritan Hematology and Oncology ConsultingCorvallisOregon--
Providence Portland Medical CenterPortlandOregon--
Penn State Milton S Hershey Medical CenterHersheyPennsylvania--
Eastern Regional Medical CenterPhiladelphiaPennsylvania--
Associates in Hematology-Oncology PCUplandPennsylvania--
Charleston Oncology Hematology AssociatesCharlestonSouth Carolina--
Baptist Regional Cancer CenterKnoxvilleTennessee--
University of Texas Medical BranchGalvestonTexas--
Jabboury Foundation for Cancer Research IncHoustonTexas--
The Methodist Hospital Research InstituteHoustonTexas--
Fletcher Allen Healthcare Inc.BurlingtonVermont--
Community Cancer Center at Rutland Regional Medical CenterRutlandVermont--
Peninsula Cancer InstituteNewport NewsVirginia--
Madigan Army Medical CenterTacomaWashington--

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Arizona Clinical Research Center· Tucson, AZComprehensive Blood and Cancer Center· Bakersfield, CAAlta Bates Summit Comprehensive Cancer Center· Berkeley, CABay Area Cancer Research Group, LLC· Concord, CASt. Jude Heritage Healthcare· Fullerton, CAWilshire Oncology Medical Group Inc· Inland Valleys/Pomona, CA

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