Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

This study has been terminated.
(NCT01318642: Planned independent DMC Interim review: ended for futility w/no safety concerns)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01318642
First received: March 17, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Pancreas
Locally Advanced
Unresectable
Drug: Gemcitabine
Drug: AMG 479
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

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. [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival and overall survival rates at 3, 6, 9, 12, 18, and 24 months [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
  • Objective response rate (complete or partial response) per RECIST v1.1 [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo + Gemcitabine
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Drug: Gemcitabine
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Other Name: Gemzar
Drug: Placebo
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
Experimental: AMG 479 20 mg/kg + Gemcitabine
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.
Drug: Gemcitabine
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Other Name: Gemzar
Drug: AMG 479
Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
Other Name: gemcitabine = Gemzar

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318642

  Hide Study Locations
Locations
United States, California
Research Site
San Francisco, California, United States, 94115
United States, Tennessee
Research Site
Knoxville, Tennessee, United States, 37909
Austria
Research Site
Salzburg, Austria, 5020
Research Site
Steyer, Austria, 4400
Research Site
Wien, Austria, 1090
Belgium
Research Site
Edegem, Belgium, 2650
Research Site
Haine St. Paul - La Louviere, Belgium, 7100
Czech Republic
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Olomouc, Czech Republic, 775 20
Research Site
Praha 10, Czech Republic, 100 34
Denmark
Research Site
Herlev, Denmark, 2730
Germany
Research Site
Hamburg, Germany, 20249
Hungary
Research Site
Budapest, Hungary, 1097
Research Site
Debrecen, Hungary, 4012
Research Site
Miskolc, Hungary, 3526
Research Site
Szolnok, Hungary, 5004
Korea, Republic of
Research Site
Seoul, Korea, Republic of, 152-703
Research Site
Seoul, Korea, Republic of, 120-752
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 138-736
Poland
Research Site
Lodz, Poland, 93-509
Research Site
Poznan, Poland, 60-569
Research Site
Warszawa, Poland, 02-097
Portugal
Research Site
Lisboa, Portugal, 1649-035
Research Site
Porto, Portugal, 4200-072
Russian Federation
Research Site
Chelyabinsk, Russian Federation, 454087
Research Site
Moscow, Russian Federation, 115478
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
Samara, Russian Federation, 443031
Spain
Research Site
Barcelona, Cataluña, Spain, 08035
Research Site
Madrid, Spain, 28050
Research Site
Madrid, Spain, 28034
United Kingdom
Research Site
Guys Hospital, United Kingdom, SE1 9RT
Research Site
London, United Kingdom, W12 0HS
Research Site
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01318642     History of Changes
Other Study ID Numbers: 20080261, 2010-023978-39
Study First Received: March 17, 2011
Last Updated: August 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Schulman Associates IRB

Keywords provided by Amgen:
Adenocarcinoma
pancreas
pancreatic cancer
local
unresectable
stage II
stage III

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatin
Pancrelipase
Gemcitabine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014