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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00657137
First received: March 31, 2008
Last updated: March 13, 2012
Last verified: March 2012
  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 2

Study Type: 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
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

Resource links provided by NLM:


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 ]

Enrollment: 12
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  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
  • Prior lapatinib therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657137

  Show 44 Study Locations
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
Study Director: Sara Zaknoen, M.D. Tragara Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00657137     History of Changes
Other Study ID Numbers: TP2001-202, APRiCOT-B
Study First Received: March 31, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

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
Fluorouracil
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014