A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

August 31, 2015 updated by: Astellas Pharma Inc

A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.

Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.

Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • France
      • Clermont-Ferrand, France
        • CHU Estaing
      • Le Mans Cedex, France
        • Centre Jean Bernard, Oncologie médicale
      • Lille, France
        • Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret
      • Pessac, France
        • Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie
      • Poitiers Cedex, France
        • Centre Hospitalier Universitaire de Poitiers
      • Rouen, France
        • Hopital Charles Nicolle
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
      • Ivanovo, Russian Federation
        • Regional Oncology Dispensary
      • Kazan, Russian Federation
        • Clinical Oncology Dispensary of Republic of Tatarstan
      • Kuzmolovo, Russian Federation
        • State Healthcare Institution "Leningrad Regional Oncologic Dispensary"
      • Moscow, Russian Federation
        • Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"
      • Obninsk, Russian Federation
        • Medical Radiology Research Center of Russian Medical Academy
      • Omsk, Russian Federation
        • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
      • Saint Petersburg, Russian Federation
        • State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
      • St. Petersburg, Russian Federation
        • Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"
  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
      • Madrid, Spain
      • Toledo, Spain
        • Hospital Virgen de la Salud, Servicio Oncologia
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego Medical Center
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Palm Beach Institute of Hematology and Oncology
      • Miami, Florida, United States, 33136
        • University of Miami
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Medical Oncology LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Oncology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia G. Piper Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • Syracuse, New York, United States, 13210
        • Regional Oncology Center
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest Region Oncology Hematology
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Baptist Regional Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center, Div. of Medical Oncology
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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:

  • Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
  • Non-measurable or measurable disease based on the RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Life expectancy of > 3 months

  • Hematologic function, as follows:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL (transfusion independent)

  • Renal function, as follows:

    • Creatinine ≤ 2.0 mg/dL

  • Hepatic function, as follows:

    • Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
    • Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
    • Bilirubin ≤ 2 x ULN
  • INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Exclusion Criteria:

  • Prior systemic therapy for metastatic pancreatic cancer

    • Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
    • Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
  • Chemotherapy and/or radiation within 4 weeks of study enrollment
  • Prior monoclonal antibody therapy within 60 days of study enrollment
  • Known brain or leptomeningeal disease

  • History of other primary malignancy, unless:

    • Curatively resected non-melanomatous skin cancer
    • Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
  • Use of any investigational product within 4 weeks of study enrollment
  • Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
  • Women who are pregnant (confirmed by positive pregnancy test) or lactating
  • Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
  • Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
  • Active serious infection not controlled with antibiotics

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. Gemcitabine monotherapy
Biological: Gemcitabine
IV infusion
Experimental: 2. Gemcitabine plus AGS-1C4D4
Biological: Gemcitabine
IV infusion
Biological: AGS-1C4D4
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study
Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study
Progression free survival (PFS)
Time Frame: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study
Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study
Change in level of serum tumor marker CA 19-9
Time Frame: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period
Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period
Incidence of anti-AGS-1C4D4 antibody formation
Time Frame: Week 1, Week 7 and every 8 weeks during the extended treatment period
Week 1, Week 7 and every 8 weeks during the extended treatment period
Objective Response Rate (Partial Response or better per RECIST criteria version 1.1
Time Frame: Week 8, and every 8 weeks during the extended treatment period
Week 8, and every 8 weeks during the extended treatment period
Disease Control (Stable Disease or better per RECIST criteria)
Time Frame: Week 8, and every 8 weeks during the extended treatment period
Week 8, and every 8 weeks during the extended treatment period

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Agensys, Inc.

Investigators

  • Study Director: Chief Medical Officer, Agensys, 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

April 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008002
  • 2009-009194-99 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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