drugset / Trial / NCT00657137

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

NCT00657137

Phase 2 Terminated 12 enrolled Tragara Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject apricoxib Small molecule 400 mg
Background Capecitabine Small molecule
Background Lapatinib Small molecule

Indications