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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)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apricoxib + lapatinib + capecitabine
placebo + lapatinib + capecitabine
Sponsored by
Tragara Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HER2/neu positive, locally advanced or metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Clinical Research Center
  • Comprehensive Blood and Cancer Center
  • Alta Bates Summit Comprehensive Cancer Center
  • Bay Area Cancer Research Group, LLC
  • St. Jude Heritage Healthcare
  • Wilshire Oncology Medical Group Inc
  • UCLA
  • Olive View- UCLA Medical Center
  • Cancer Care Associates Medical Group Inc
  • North America Research Institute
  • Central Coast Medical Oncology Corporation
  • Front Range Cancer Specialists
  • Hematology Oncology Associates
  • MD Anderson Cancer Center in Orlando
  • Suburban Hematology-Oncology Associates
  • Warren Billhartz Cancer Center
  • Mid-Illinois Hematology Oncology Associates
  • Medical Consultants PC
  • SJMH Cancer Center
  • Genesys Hurley Cancer Center Institute
  • Foote Health System
  • Bresline Cancer Center at Michigan State University
  • St. Mary Mercy Hospital
  • Mercy Hospital
  • St. Mary's of Michigan
  • St. Francis Cancer Treatment Center
  • Warren Hospital
  • San Juan Oncology Associates
  • Flower Hospital Cancer Center
  • University of Toledo
  • Samaritan Hematology and Oncology Consulting
  • Providence Portland Medical Center
  • Penn State Milton S Hershey Medical Center
  • Eastern Regional Medical Center
  • Associates in Hematology-Oncology PC
  • Charleston Oncology Hematology Associates
  • Baptist Regional Cancer Center
  • University of Texas Medical Branch
  • Jabboury Foundation for Cancer Research Inc
  • The Methodist Hospital Research Institute
  • Fletcher Allen Healthcare Inc.
  • Community Cancer Center at Rutland Regional Medical Center
  • Peninsula Cancer Institute
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

apricoxib + lapatinib + capecitabine

placebo + lapatinib + capecitabine

Outcomes

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.

Secondary Outcome Measures

Progression-free survival and safety/tolerability

Full Information

First Posted
March 31, 2008
Last Updated
March 13, 2012
Sponsor
Tragara Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00657137
Brief Title
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
Acronym
APRiCOT-B
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tragara Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HER2/neu positive, locally advanced or metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
apricoxib + lapatinib + capecitabine
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo + lapatinib + capecitabine
Intervention Type
Drug
Intervention Name(s)
apricoxib + lapatinib + capecitabine
Intervention Description
apricoxib: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert
Intervention Type
Drug
Intervention Name(s)
placebo + lapatinib + capecitabine
Intervention Description
placebo: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Progression-free survival and safety/tolerability
Time Frame
Time to disease progression

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Zaknoen, M.D.
Organizational Affiliation
Tragara Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Alta Bates Summit Comprehensive Cancer Center
City
Berkeley
State/Province
California
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Concord
State/Province
California
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
Country
United States
Facility Name
Wilshire Oncology Medical Group Inc
City
Inland Valleys/Pomona
State/Province
California
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Olive View- UCLA Medical Center
City
Olive View
State/Province
California
Country
United States
Facility Name
Cancer Care Associates Medical Group Inc
City
Redondo Beach
State/Province
California
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
Country
United States
Facility Name
Front Range Cancer Specialists
City
Ft. Collins
State/Province
Colorado
Country
United States
Facility Name
Hematology Oncology Associates
City
Lake Worth
State/Province
Florida
Country
United States
Facility Name
MD Anderson Cancer Center in Orlando
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Suburban Hematology-Oncology Associates
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Warren Billhartz Cancer Center
City
Maryville
State/Province
Illinois
Country
United States
Facility Name
Mid-Illinois Hematology Oncology Associates
City
Normal
State/Province
Illinois
Country
United States
Facility Name
Medical Consultants PC
City
Muncie
State/Province
Indiana
Country
United States
Facility Name
SJMH Cancer Center
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Genesys Hurley Cancer Center Institute
City
Flint
State/Province
Michigan
Country
United States
Facility Name
Foote Health System
City
Jackson County
State/Province
Michigan
Country
United States
Facility Name
Bresline Cancer Center at Michigan State University
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Mercy Hospital
City
Port Huron
State/Province
Michigan
Country
United States
Facility Name
St. Mary's of Michigan
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
St. Francis Cancer Treatment Center
City
Grand Island
State/Province
Nebraska
Country
United States
Facility Name
Warren Hospital
City
Phillipsburg
State/Province
New Jersey
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
Country
United States
Facility Name
Flower Hospital Cancer Center
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Samaritan Hematology and Oncology Consulting
City
Corvallis
State/Province
Oregon
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Associates in Hematology-Oncology PC
City
Upland
State/Province
Pennsylvania
Country
United States
Facility Name
Charleston Oncology Hematology Associates
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Baptist Regional Cancer Center
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
Country
United States
Facility Name
Jabboury Foundation for Cancer Research Inc
City
Houston
State/Province
Texas
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
Country
United States
Facility Name
Fletcher Allen Healthcare Inc.
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Community Cancer Center at Rutland Regional Medical Center
City
Rutland
State/Province
Vermont
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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