Study Stopped
NCT01318642: Planned independent DMC Interim review: ended for futility
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
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
2 other identifiers
interventional
10
13 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2012
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedStudy Start
First participant enrolled
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2012
CompletedResults Posted
Study results publicly available
November 8, 2024
CompletedNovember 8, 2024
May 1, 2024
6 months
March 17, 2011
April 18, 2024
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
From randomization to the date of either disease progression or death, up to 181 days progression or death
Secondary Outcomes (5)
Overall Survival
Up to 181 days
Number of Participants With Adverse Events
Up to 4 months
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Up to 181 days
Duration of Response
Up to 181 days
Number of Participants With Anti-AMG 479 Antibodies
Up to 181 days
Study Arms (2)
Placebo + Gemcitabine
ACTIVE COMPARATORArm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
AMG 479 20 mg/kg + Gemcitabine
EXPERIMENTALARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Interventions
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Research Site
San Francisco, California, 94115, United States
Research Site
Knoxville, Tennessee, 37909, United States
Research Site
Salzburg, 5020, Austria
Research Site
Steyr, 4400, Austria
Research Site
Vienna, 1090, Austria
Research Site
Edegem, 2650, Belgium
Research Site
La Louvière, 7100, Belgium
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Olomouc, 775 20, Czechia
Research Site
Prague, 100 34, Czechia
Research Site
Herlev, 2730, Denmark
Research Site
Hamburg, 20249, Germany
Research Site
Budapest, 1097, Hungary
Research Site
Debrecen, 4012, Hungary
Research Site
Miskolc, 3526, Hungary
Research Site
Szolnok, 5004, Hungary
Research Site
Lodz, 93-509, Poland
Research Site
Poznan, 60-569, Poland
Research Site
Warsaw, 02-097, Poland
Research Site
Lisbon, 1649-035, Portugal
Research Site
Porto, 4200-072, Portugal
Research Site
Chelyabinsk, 454087, Russia
Research Site
Moscow, 115478, Russia
Research Site
Saint Petersburg, 197022, Russia
Research Site
Samara, 443031, Russia
Research Site
Seoul, 120-752, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Seoul, 138-736, South Korea
Research Site
Seoul, 152-703, South Korea
Research Site
Barcelona, Cataluña, 08035, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28050, Spain
Guys Hospital
London, SE1 9RT, United Kingdom
Research Site
London, W12 0HS, United Kingdom
Research Site
Preston, PR2 9HT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early. Only the safety data is provided.
Results Point of Contact
- Title
- Sandeep Bobby Reddy, Chief Medical Officer
- Organization
- ImmunityBio
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2011
First Posted
March 18, 2011
Study Start
May 31, 2012
Primary Completion
November 27, 2012
Study Completion
December 3, 2012
Last Updated
November 8, 2024
Results First Posted
November 8, 2024
Record last verified: 2024-05