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

Sponsor
Hoffmann-La Roche
Study ID
NCT02694536
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
  • Gemcitabine — DRUG
    Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Study Details

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.

Key Dates

First listed
Feb 29, 2016
Start date
Aug 1, 2006
Status verified
Feb 2017
Primary completion
Nov 19, 2009
Completion
Nov 19, 2009

Study Design

Enrollment
80 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 40 months (assessed continuously during treatment) ]

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