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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)

NCT00657137 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-03-15

No results posted yet for this study

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

Interventions

DRUG

apricoxib + lapatinib + capecitabine

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

DRUG

placebo + lapatinib + capecitabine

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

Sponsors & Collaborators

  • Tragara Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sara Zaknoen, M.D. · Tragara Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657137 on ClinicalTrials.gov