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

Summary

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.

Conditions

• 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

Interventions

DRUG

AMG 479

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

DRUG

Placebo

Placebo administered intravenously on days 1 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

Sponsors & Collaborators

• Takeda

  collaborator INDUSTRY

• NantCell, Inc.

  lead INDUSTRY

Principal Investigators

• NantKWest Clinical Review Team · ImmunityBio, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-07

Primary Completion

2012-12-12

Completion

2012-12-12

Countries

• United States
• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• Canada
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Hong Kong
• Hungary
• Italy
• Japan
• Lithuania
• Netherlands
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Slovakia
• Slovenia
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• United Kingdom

Study Locations