Clinical trial · Interventional
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer
NCT00709826CI-TRIAL-00008435completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apricoxib | Drug | — | UNRESOLVED |
| Erlotinib | Drug | Erlotinib | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- apricoxib + gemcitabine + erlotinib
- description
- 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
- interventionNames
- Drug: gemcitabine
- Drug: Erlotinib
- Drug: apricoxib
- type
- PLACEBO_COMPARATOR
- label
- placebo + gemcitabine + erlotinib
- description
- placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
- interventionNames
- Drug: gemcitabine
- Drug: placebo
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic. 2. Life expectancy greater than or equal to 3 months. 3. Patients must have measurable disease by RECIST. 4. ECOG PS of 0, 1, or 2. 5. Negative serum pregnancy test at the time of first dose for women of childbearing potential. Exclusion Criteria: 1. Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4). 2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment. 3. Evidence of New York Heart Association class III or greater cardiac disease. 4. History of myocardial infarction, stroke, ventricular arrhythmia. 5. Symptomatic central nervous system metastases. 6. Pregnant or nursing women. 7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). 8. History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months. 9. Previous anti-EGFR kinase therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.