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

March 13, 2012 updated by: Tragara Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Arizona Clinical Research Center
    • California
      • Bakersfield, California, United States
        • Comprehensive Blood And Cancer Center
      • Berkeley, California, United States
        • Alta Bates Summit Comprehensive Cancer Center
      • Concord, California, United States
        • Bay Area Cancer Research Group, LLC
      • Fullerton, California, United States
        • St. Jude Heritage Healthcare
      • Inland Valleys/Pomona, California, United States
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, United States
        • UCLA
      • Olive View, California, United States
        • Olive View- UCLA Medical Center
      • Redondo Beach, California, United States
        • Cancer Care Associates Medical Group Inc
      • San Dimas, California, United States
        • North America Research Institute
      • Santa Maria, California, United States
        • Central Coast Medical Oncology Corporation
    • Colorado
      • Ft. Collins, Colorado, United States
        • Front Range Cancer Specialists
    • Florida
      • Lake Worth, Florida, United States
        • Hematology Oncology Associates
      • Orlando, Florida, United States
        • MD Anderson Cancer Center in Orlando
    • Georgia
      • Lawrenceville, Georgia, United States
        • Suburban Hematology-Oncology Associates
    • Illinois
      • Maryville, Illinois, United States
        • Warren Billhartz Cancer Center
      • Normal, Illinois, United States
        • Mid-Illinois Hematology Oncology Associates
    • Indiana
      • Muncie, Indiana, United States
        • Medical Consultants PC
    • Michigan
      • Ann Arbor, Michigan, United States
        • SJMH Cancer Center
      • Flint, Michigan, United States
        • Genesys Hurley Cancer Center Institute
      • Jackson County, Michigan, United States
        • Foote Health System
      • Lansing, Michigan, United States
        • Bresline Cancer Center at Michigan State University
      • Livonia, Michigan, United States
        • St. Mary Mercy Hospital
      • Port Huron, Michigan, United States
        • Mercy Hospital
      • Saginaw, Michigan, United States
        • St. Mary's of Michigan
    • Nebraska
      • Grand Island, Nebraska, United States
        • St. Francis Cancer Treatment Center
    • New Jersey
      • Phillipsburg, New Jersey, United States
        • Warren Hospital
    • New Mexico
      • Farmington, New Mexico, United States
        • San Juan Oncology Associates
    • Ohio
      • Sylvania, Ohio, United States
        • Flower Hospital Cancer Center
      • Toledo, Ohio, United States
        • University of Toledo
    • Oregon
      • Corvallis, Oregon, United States
        • Samaritan Hematology and Oncology Consulting
      • Portland, Oregon, United States
        • Providence Portland Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States
        • Eastern Regional Medical Center
      • Upland, Pennsylvania, United States
        • Associates in Hematology-Oncology PC
    • South Carolina
      • Charleston, South Carolina, United States
        • Charleston Oncology Hematology Associates
    • Tennessee
      • Knoxville, Tennessee, United States
        • Baptist Regional Cancer Center
    • Texas
      • Galveston, Texas, United States
        • University of Texas Medical Branch
      • Houston, Texas, United States
        • The Methodist Hospital Research Institute
      • Houston, Texas, United States
        • Jabboury Foundation for Cancer Research Inc
    • Vermont
      • Burlington, Vermont, United States
        • Fletcher Allen Healthcare Inc.
      • Rutland, Vermont, United States
        • Community Cancer Center at Rutland Regional Medical Center
    • Virginia
      • Newport News, Virginia, United States
        • Peninsula Cancer Institute
    • Washington
      • Tacoma, Washington, United States
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time to disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival and safety/tolerability
Time Frame: Time to disease progression
Time to disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tragara Pharmaceuticals, Inc.

Investigators

  • Study Director: Sara Zaknoen, M.D., Tragara Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (ESTIMATE)

April 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP2001-202
  • APRiCOT-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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