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

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 I Phase II

MedlinePlus related topics:

Cancer Pancreatic Cancer

Drug Information available for:

Gemcitabine hydrochloride Gemcitabine Insulin Insulin-like growth factor I Mecasermin rinfabate Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Amgen:

Primary Outcome Measures:

Survival [ Time Frame: 6 months ] [ 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 ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo + Gemcitabine: Placebo Comparator	Other: Placebo Inactive dummy of AMG 655.
AMG 655 + Gemcitabine: Experimental	Drug: AMG 655 AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
AMG 479 + Gemcitabine: Experimental	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

Contacts


Contact: Amgen Call Center	866-572-6436

Show 29 Study Locations

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060323
First Received:	February 28, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00630552
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

Adenocarcinoma of the Pancreas

Metastatic Pancreatic Cancer

Pancreatic cancer

Study placed in the following topic categories:

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancrelipase

Insulin

Carcinoma

Antibodies

Digestive System Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Endocrinopathy

Adenocarcinoma

Gemcitabine

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00630552