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

NCT00657137 | Terminated Phase 2 DMC

• 2 other identifiers: TP2001-202APRiCOT-B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 44

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.

Conditions

Breast Cancer

Keywords

HER2/neu positive; locally advanced or metastatic

Outcome Measures

Primary Outcomes (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 to disease progression

Secondary Outcomes (1)

• Progression-free survival and safety/tolerability

  Time to disease progression

Study Arms (2)

A

EXPERIMENTAL

apricoxib + lapatinib + capecitabine

Drug: apricoxib + lapatinib + capecitabine

B

PLACEBO COMPARATOR

placebo + lapatinib + capecitabine

Drug: placebo + lapatinib + capecitabine

Interventions

apricoxib + lapatinib + capecitabine DRUG

apricoxib: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert

A

placebo + lapatinib + capecitabine DRUG

placebo: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Tragara Pharmaceuticals, Inc.: lead

Study Sites (44)

Arizona Clinical Research Center

Tucson, Arizona, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Location

Bay Area Cancer Research Group, LLC

Concord, California, United States

Location

St. Jude Heritage Healthcare

Fullerton, California, United States

Location

Wilshire Oncology Medical Group Inc

Inland Valleys/Pomona, California, United States

Location

UCLA

Los Angeles, California, United States

Location

Olive View- UCLA Medical Center

Olive View, California, United States

Location

Cancer Care Associates Medical Group Inc

Redondo Beach, California, United States

Location

North America Research Institute

San Dimas, California, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Location

Hematology Oncology Associates

Lake Worth, Florida, United States

Location

MD Anderson Cancer Center in Orlando

Orlando, Florida, United States

Location

Suburban Hematology-Oncology Associates

Lawrenceville, Georgia, United States

Location

Warren Billhartz Cancer Center

Maryville, Illinois, United States

Location

Mid-Illinois Hematology Oncology Associates

Normal, Illinois, United States

Location

Medical Consultants PC

Muncie, Indiana, United States

Location

SJMH Cancer Center

Ann Arbor, Michigan, United States

Location

Genesys Hurley Cancer Center Institute

Flint, Michigan, United States

Location

Foote Health System

Jackson County, Michigan, United States

Location

Bresline Cancer Center at Michigan State University

Lansing, Michigan, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, United States

Location

Mercy Hospital

Port Huron, Michigan, United States

Location

St. Mary's of Michigan

Saginaw, Michigan, United States

Location

St. Francis Cancer Treatment Center

Grand Island, Nebraska, United States

Location

Warren Hospital

Phillipsburg, New Jersey, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Location

University of Toledo

Toledo, Ohio, United States

Location

Samaritan Hematology and Oncology Consulting

Corvallis, Oregon, United States

Location

Providence Portland Medical Center

Portland, Oregon, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Location

Associates in Hematology-Oncology PC

Upland, Pennsylvania, United States

Location

Charleston Oncology Hematology Associates

Charleston, South Carolina, United States

Location

Baptist Regional Cancer Center

Knoxville, Tennessee, United States

Location

University of Texas Medical Branch

Galveston, Texas, United States

Location

Jabboury Foundation for Cancer Research Inc

Houston, Texas, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, United States

Location

Fletcher Allen Healthcare Inc.

Burlington, Vermont, United States

Location

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, United States

Location

Madigan Army Medical Center

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

apricoxib; Lapatinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sara Zaknoen, M.D.

  Tragara Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (44)