Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Adenocarcinoma of the Pancreas, Locally Advanced, Unresectable
In brief
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.
Key facts
- Study ID
- NCT01318642
- Run by
- NantBioScience, Inc.
- People needed
- 10
- Starts
- 2012-05-31
- Expected to finish
- 2012-12-03
- Last updated by the study team
- 2024-11-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
- Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women >/= 18 years of age
- Adequate organ function
You may not qualify if…
- Early (stage I) or metastatic (stage IV) disease
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
- External biliary drain
- Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
Where it is running
- Research Site — San Francisco, California, United States
- Research Site — Knoxville, Tennessee, United States
- Research Site — Salzburg, Austria
- Research Site — Steyr, Austria
- Research Site — Vienna, Austria
- Research Site — Edegem, Belgium
- Research Site — La Louvière, Belgium
- Research Site — Hradec Králové, Czechia
- Research Site — Olomouc, Czechia
- Research Site — Prague, Czechia
- 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 — Lodz, Poland
- Research Site — Poznan, Poland
- Research Site — Warsaw, Poland
- Research Site — Lisbon, Portugal
- Research Site — Porto, Portugal
- Research Site — Chelyabinsk, Russia
- Research Site — Moscow, Russia
- Research Site — Saint Petersburg, Russia
- Research Site — Samara, Russia
Full record on ClinicalTrials.gov
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