Clinical trial NCT01318642: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenocarcinoma of the Pancreas
Locally Advanced
Unresectable
Keywords: Adenocarcinoma
pancreas
pancreatic cancer
local
unresectable
stage II
stage III
Lead sponsor: NantBioScience, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
timeFrame: From randomization to the date of either disease progression or death, up to 181 days progression or death
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 181 days
measure: Number of Participants With Adverse Events
timeFrame: Up to 4 months
measure: Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
timeFrame: Up to 181 days
measure: Duration of Response
timeFrame: Up to 181 days
measure: Number of Participants With Anti-AMG 479 Antibodies
timeFrame: Up to 181 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Site
state: California
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Salzburg
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: La Louviere
country: Belgium
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: Research Site
city: Preston
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: