Status:
COMPLETED
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
Lead Sponsor:
NantCell, Inc.
Conditions:
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-escala...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00630552
Start Date
June 1 2007
End Date
April 1 2012
Last Update
October 17 2024
Active Locations (44)
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1
Research Site
Alhambra, California, United States, 91801
2
Research Site
Bakersfield, California, United States, 93309
3
Research Site
Fullerton, California, United States, 92835
4
Research Site
La Jolla, California, United States, 92093