A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas - GAMMA

• Conditions: metastatic adenocarcinoma of the pancreas; MedDRA version: 12.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastatic; MedDRA version: 12.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectable

• Registration Number: EUCTR2010-020398-18-SI
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-02
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

Subjects must have histologically or cytologically confirmed metastatic
adenocarcinoma of the pancreas (American Joint Committee on Cancer Stage IV); ECOG score of 0 or 1; Men or women = 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma,
sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma; currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (eg, gemcitabine), radiotherapy, chemoradiotherapy or other agents for pancreatic cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified