Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20060323

NCT ID:

NCT00630552

Start Date:

June 2007

Completion Date:

April 2012

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Metastatic Pancreatic Cancer
  • Pancreatic Cancer
  • AMG 479
  • Gemcitabine
  • TR-2
  • IGF-1R
  • AMG 655
  • Pancreatic cancer
  • Adenocarcinoma of the Pancreas
  • Metastatic Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBranson, Missouri  
Research SiteLas Vegas, Nevada  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteAbilene, Texas  
Research SiteAuburn, Washington