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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tragara Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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