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A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer


Inclusion Criteria:



- adult patients, >=18 years of age;

- metastatic pancreatic cancer (adenocarcinoma);

- good liver, kidney, and bone marrow function.

Exclusion Criteria:

- previous systemic treatment for metastatic pancreatic cancer;

- pregnant or lactating females;

- fertile men, or women of childbearing potential, not using adequate contraception;

- major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start;

- current or recent treatment (within 30 days prior to starting study treatment) with
another investigational drug, or participation in another investigational study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

Up to approximately 33 months from first patient randomized

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Ministry of Health

Study ID:

BO17706

NCT ID:

NCT01214720

Start Date:

Completion Date:

October 2008

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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