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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NantCell, Inc.
• Collaborator: Takeda
• Treatments: Antibodies, Monoclonal; Gemcitabine; Pancreatin; Pancrelipase

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