A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

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Roche

Status and phase

Completed
Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine
Drug: Erlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02694536
2005-004605-29 (EudraCT Number)
ML19537

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Erlotinib + Gemcitabine
Experimental group
Description:
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Treatment:
Drug: Erlotinib
Drug: Gemcitabine

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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