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QUILT-2.014: 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:
ClinicalTrials.gov Identifier:
NCT01231347
First Posted: November 1, 2010
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
NantCell, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 NantCell, Inc.:

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 ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: After 825 subjects randomized + 24 months ]
  • Objective response rate [ Time Frame: After 825 subjects randomized + 24 months ]
  • Time to disease progression [ Time Frame: After 825 subjects randomized + 24 months ]
  • Disease control rate [ Time Frame: After 825 subjects randomized + 24 months ]
  • Number of subjects with adverse events [ Time Frame: After 825 subjects randomized + 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231347


  Show 165 Study Locations
Sponsors and Collaborators
NantCell, Inc.
Takeda
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT01231347     History of Changes
Other Study ID Numbers: 20060540
GAMMA
QUILT-2.014 ( Other Identifier: NantCell, Inc. )
First Submitted: October 14, 2010
First Posted: November 1, 2010
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by NantCell, Inc.:
pancreas
gemcitabine
metastatic
jaundice

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antibodies, Monoclonal
Pancrelipase
Pancreatin
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
Gastrointestinal Agents