Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apricoxib + lapatinib + capecitabine | Drug | — | UNRESOLVED |
| placebo + lapatinib + capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- apricoxib + lapatinib + capecitabine
- interventionNames
- Drug: apricoxib + lapatinib + capecitabine
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- placebo + lapatinib + capecitabine
- interventionNames
- Drug: placebo + lapatinib + capecitabine
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available