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OpenTrials
Completed

NCT Number: NCT01231347

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

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

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Key information

Conditions

Adenocarcinoma of the Pancreas Advanced Malignancy Advanced Solid Tumors Bone Metastases Cancer Cancer of Pancreas Cancer of the Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Cancer Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Metastases Metastatic Cancer Metastatic Pancreatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Oncology Oncology Patients Pancreas Cancer Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 479

Drug

AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

Placebo

Drug

Placebo administered intravenously on days 1 and 15 of a 28 day cycle

Gemcitabine

Drug

gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Other names: Gemzar

Primary outcomes

  1. Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg 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: From randomization up to 20 months

    The primary endpoint of the study was OS, defined as the time from randomization to death.

Sponsors and collaborators

Lead sponsor

NantCell, Inc.

Industry

Collaborators

  • Takeda

Registry information

Official study 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

Acronym: GAMMA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2010
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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