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A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.


Inclusion Criteria:



- adult patients, >=18 years of age;

- histologically or cytologically documented locally advanced-unresectable or
metastatic pancreatic cancer;

- measurable disease according to RECIST;

- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for
chemotherapy;

- ECOG performance status of 0-2.

Exclusion Criteria:

- local or locally advanced-resectable pancreatic cancer;

- any other malignancies within last 5 years, except for adequately treated cancer in
situ of the cervix, or basal or squamous cell skin cancer;

- major surgery within 2 weeks prior to randomization.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serum

Outcome Time Frame:

At screening

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Malaysia: Ministry of Health

Study ID:

BO21129

NCT ID:

NCT00674973

Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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