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

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ClinicalTrials.gov Identifier: NCT00657137
Recruitment Status : Terminated (Slow accrual)
First Posted : April 14, 2008
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: apricoxib + lapatinib + capecitabine Drug: placebo + lapatinib + capecitabine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
apricoxib + lapatinib + capecitabine
Drug: apricoxib + lapatinib + capecitabine

apricoxib: 100 mg tablets, 400 mg/day

lapatinib: per package insert

capecitabine: per package insert

Placebo Comparator: B
placebo + lapatinib + capecitabine
Drug: placebo + lapatinib + capecitabine

placebo: 100 mg tablets, 400 mg/day

lapatinib: per package insert

capecitabine: per package insert



Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Progression-free survival and safety/tolerability [ Time Frame: Time to disease progression ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
  • Prior lapatinib therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657137


  Show 44 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.
ClinicalTrials.gov Identifier: NCT00657137     History of Changes
Other Study ID Numbers: TP2001-202
APRiCOT-B
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by Tragara Pharmaceuticals, Inc.:
HER2/neu positive
locally advanced or metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors