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Spots Global Cancer Trial Database for Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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