QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

October 26, 2016 updated by: NantCell, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91801
        • Research Site
      • Bakersfield, California, United States, 93309
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • La Jolla, California, United States, 92093
        • Research Site
      • Long Beach, California, United States, 90813
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Northridge, California, United States, 91328
        • Research Site
      • Oxnard, California, United States, 93030
        • Research Site
      • Rancho Mirage, California, United States, 92270
        • Research Site
      • Redondo Beach, California, United States, 90277
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
      • Santa Monica, California, United States, 90403
        • Research Site
    • Florida
      • Miami, Florida, United States, 33136
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Atlanta, Georgia, United States, 30341
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Harvey, Illinois, United States, 60426
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Research Site
      • Westminster, Maryland, United States, 21157
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
    • New York
      • Albany, New York, United States, 12206
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Hickory, North Carolina, United States, 28602
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15261
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Austin, Texas, United States, 78705
        • Research Site
      • Austin, Texas, United States, 78731
        • Research Site
      • Dallas, Texas, United States, 75246
        • Research Site
      • Round Rock, Texas, United States, 78681
        • Research Site
      • Tyler, Texas, United States, 75702
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site
      • Yakima, Washington, United States, 98902
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 6 months
6 months
Safety
Time Frame: Length of the study
Length of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Efficacy Endpoints
Time Frame: Length of the study
Length of the study
Overall Survival
Time Frame: Length of the study
Length of the study
Time to Response
Time Frame: Length of the study
Length of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NantCell, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060323
  • QUILT-2.019 (Other Identifier: NantCell, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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