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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00630552
First received: February 28, 2008
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
Pancreatic Cancer
Other: Placebo
Drug: AMG 479
Drug: AMG 655
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Length of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Efficacy Endpoints [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: Length of the study ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: June 2007
Study Completion Date: April 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Gemcitabine Other: Placebo
Inactive dummy of AMG 655.
Experimental: AMG 655 + Gemcitabine Drug: AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Experimental: AMG 479 + Gemcitabine Drug: AMG 479
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630552

  Show 50 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00630552     History of Changes
Other Study ID Numbers: 20060323
Study First Received: February 28, 2008
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board

Keywords provided by Amgen:
AMG 479
Gemcitabine
TR-2
IGF-1R
AMG 655
Pancreatic cancer
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014