A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214720

BO17706

Details and patient eligibility

About

This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

Enrollment: 607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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607 participants in 1 patient group

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]