Clinical trial · Interventional
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
NCT02694536CI-TRIAL-00026623completedPhase 3Results 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 open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib + Gemcitabine
- description
- Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
- interventionNames
- Drug: Erlotinib
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs)
- timeFrame
- Up to approximately 40 months (assessed continuously during treatment)
- description
- An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease * No prior systemic treatment for metastatic disease * Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 * Life expectancy ≥12 weeks * Adequate hematologic, hepatic, and renal function * Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential Exclusion Criteria: * Unstable systemic disease * Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors * Other malignancy within 5 years prior to study entry * Significant opthalmologic abnormality * Inability to take oral medication * Need for IV alimentation * Prior surgery affecting absorption * Active peptic ulcer disease * Nursing mothers
References
Publications (0)
Data not yet available
No reference posted for this study.