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Brief Title: Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
Study ID: NCT01318642
Brief Summary: This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Detailed Description: This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, San Francisco, California, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Salzburg, , Austria
Research Site, Steyer, , Austria
Research Site, Wien, , Austria
Research Site, Edegem, , Belgium
Research Site, Haine St. Paul - La Louviere, , Belgium
Research Site, Hradec Kralove, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Praha 10, , Czech Republic
Research Site, Herlev, , Denmark
Research Site, Hamburg, , Germany
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Lodz, , Poland
Research Site, Poznan, , Poland
Research Site, Warszawa, , Poland
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Chelyabinsk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, Barcelona, Cataluña, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Guys Hospital, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Preston, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR