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Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

Primary Purpose

Adenocarcinoma of the Pancreas, Locally Advanced, Unresectable

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gemcitabine
AMG 479
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas focused on measuring Adenocarcinoma, pancreas, pancreatic cancer, local, unresectable, stage II, stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo + Gemcitabine

AMG 479 20 mg/kg + Gemcitabine

Arm Description

Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle

ARM 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.

Outcomes

Primary Outcome Measures

The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death.

Secondary Outcome Measures

Progression-free survival and overall survival rates at 3, 6, 9, 12, 18, and 24 months
Objective response rate (complete or partial response) per RECIST v1.1
Overall survival

Full Information

First Posted
March 17, 2011
Last Updated
August 6, 2014
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01318642
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
NCT01318642: Planned independent DMC Interim review: ended for futility w/no safety concerns
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Locally Advanced, Unresectable
Keywords
Adenocarcinoma, pancreas, pancreatic cancer, local, unresectable, stage II, stage III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Gemcitabine
Arm Type
Active Comparator
Arm Description
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Arm Title
AMG 479 20 mg/kg + Gemcitabine
Arm Type
Experimental
Arm Description
ARM 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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
AMG 479
Other Intervention Name(s)
gemcitabine = Gemzar
Intervention Description
Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
Primary Outcome Measure Information:
Title
The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death.
Time Frame
Approximately 23 months
Secondary Outcome Measure Information:
Title
Progression-free survival and overall survival rates at 3, 6, 9, 12, 18, and 24 months
Time Frame
Approximately 23 months
Title
Objective response rate (complete or partial response) per RECIST v1.1
Time Frame
Approximately 23 months
Title
Overall survival
Time Frame
Approximately 23 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Steyer
ZIP/Postal Code
4400
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Haine St. Paul - La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Research Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Guys Hospital
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Research Site
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

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