NCT00630552

QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Conditions

• Adenocarcinoma of the Pancreas
• Metastatic Pancreatic Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	Placebo	Inactive dummy of AMG 655.
DRUG	AMG 479	AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
DRUG	AMG 655	AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-01-01
• Completion: 2012-04-01
• First posted: 2008-03-07
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

44 sites across 1 country: United States