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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID: NCT00630552
Run by: NantCell, Inc.
People needed: 138
Starts: 2007-06-01
Expected to finish: 2012-04-01
Last updated by the study team: 2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Alhambra, California, United States
Research Site — Bakersfield, California, United States
Research Site — Fullerton, California, United States
Research Site — La Jolla, California, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Northridge, California, United States
Research Site — Oxnard, California, United States
Research Site — Rancho Mirage, California, United States
Research Site — Redondo Beach, California, United States
Research Site — San Francisco, California, United States
Research Site — Santa Maria, California, United States
Research Site — Santa Monica, California, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Marietta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Harvey, Illinois, United States
Research Site — Baltimore, Maryland, United States
Research Site — Westminster, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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