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

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.

Inclusion Criteria:

• Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
• Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.

Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.

• Men or women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Adequate hematologic, hepatic, renal and coagulation function
• Amylase and lipase ≤ 2.0 x ULN
• Adequately controlled type 1 or 2 diabetic subjects

Exclusion Criteria:

• Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
• Known central nervous system metastases
• Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
• Adjuvant chemotherapy or chemoradiotherapy