A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases, Metastatic Cancer, Metastatic Pancreatic Cancer, Pancreas Cancer, Pancreatic Cancer, Bone Metastases, Endocrine Cancer, Oncology, Oncology Patients, Solid Tumors, Advanced Malignancy
Both
Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases, Metastatic Cancer, Metastatic Pancreatic Cancer, Pancreas Cancer, Pancreatic Cancer, Bone Metastases, Endocrine Cancer, Oncology, Oncology Patients, Solid Tumors, Advanced Malignancy
Trial Information
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas
Outcome Time Frame:
After 825 subjects randomized + 24 months
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Canada: Health Canada
Study ID:
20060540
NCT ID:
NCT01231347
Start Date:
April 2011
Completion Date:
December 2014
Related Keywords:
- Adenocarcinoma of the Pancreas
- Advanced Solid Tumors
- Cancer
- Cancer of Pancreas
- Cancer of the Pancreas
- Metastases
- Metastatic Cancer
- Metastatic Pancreatic Cancer
- Pancreas Cancer
- Pancreatic Cancer
- Bone Metastases
- Endocrine Cancer
- Oncology
- Oncology Patients
- Solid Tumors
- Advanced Malignancy
- pancreas
- gemcitabine
- metastatic
- jaundice
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Pancreatic Neoplasms
- Endocrine Gland Neoplasms
- Bone Neoplasms
- Bone Marrow Diseases
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Arlington Heights, Illinois |
| Research Site | Beverly, Massachusetts |
| Research Site | Battle Kreek, Michigan |
| Research Site | Asheville, North Carolina |
| Research Site | Bend, Oregon |
| Research Site | Pawtucket, Rhode Island |
| Research Site | Charleston, South Carolina |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
| Research Site | Abington, Virginia |
| Research Site | Auburn, Washington |
