Phase 3
Completed N=80
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT02694536 ↗Enrolled (actual)
80
Serious AEs
43.8%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 78.8 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
78.8 | — |
| SECONDARY European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores |
1.96; 2.03; 1.50; 1.87; 1.21; 1.82 | — |
| SECONDARY Percentage of Participants Who Died |
73 | — |
| SECONDARY Overall Survival (OS) |
7.49 | — |
| SECONDARY Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) |
88 | — |
| SECONDARY Progression-Free Survival (PFS) According to RECIST |
4.864 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02694536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.