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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657137

Acronym

APRiCOT-B

Enrollment

Registered

2008-04-14

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

HER2/neu positive, locally advanced or metastatic

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.

Interventions

DRUGapricoxib + lapatinib + capecitabine

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

DRUGplacebo + lapatinib + capecitabine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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 to disease progression

Secondary

Measure	Time frame
Progression-free survival and safety/tolerability	Time to disease progression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026