Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas (GAMMA)

This study has been terminated.
(Planned independent DMC Interim review: ended for futility w/no safety concerns)
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01231347
First received: October 14, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.

Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.

The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.


Condition Intervention Phase
Adenocarcinoma of the Pancreas
Advanced Solid Tumors
Cancer
Cancer of Pancreas
Cancer of the Pancreas
Metastases
Metastatic Cancer
Metastatic Pancreatic Cancer
Pancreas Cancer
Pancreatic Cancer
Bone Metastases
Endocrine Cancer
Oncology
Oncology Patients
Solid Tumors
Advanced Malignancy
Drug: AMG 479
Drug: Placebo
Drug: gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 800
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 479 12 mg/kg dose + gemcitabine
Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Drug: AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Other Name: Gemzar
Placebo Comparator: Placebo + gemcitabine
Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Drug: Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Other Name: Gemzar
Active Comparator: AMG 479 20 mg/kg + gemcitabine
Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Drug: AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Other Name: Gemzar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated metastatic adenocarcinoma of the pancreas
  • Adequate hematologic, renal and liver function
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy for pancreatic cancer
  • Central nervous system metastases
  • External biliary drain
  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: NCT01231347

  Show 165 Study Locations
Sponsors and Collaborators
Amgen
Takeda
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01231347     History of Changes
Other Study ID Numbers: 20060540, 20060540, GAMMA
Study First Received: October 14, 2010
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada
United States: Dana Farber Cancer Institute IRB
United States: Food and Drug Administration
United States: Schulman Associates IRB
United States: US Oncology Institutional Review Board
United States: Western Institutional Review Board
Belgium: Centre Hospitalier de l'Ardenne comité d'éthique
Brazil: Ministry of Health
Greece: National Ethics Committee
Japan: Pharmaceuticals and Medical Devices Evaluation Center
United State: Western Institutional Review Board
Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven

Keywords provided by Amgen:
pancreas
gemcitabine
metastatic
jaundice

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Neoplasm Metastasis
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014