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

This study has been completed.
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00902291
First received: May 13, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Carcinoma, Pancreatic Ductal
Pancreatic Cancer
Pancreatic Disease
Biological: AGS-1C4D4
Biological: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of anti-AGS-1C4D4 antibody formation [ Time Frame: Week 1, Week 7 and every 8 weeks during the extended treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Disease Control (Stable Disease or better per RECIST criteria) [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Gemcitabine monotherapy Biological: Gemcitabine
IV infusion
Experimental: 2. Gemcitabine plus AGS-1C4D4 Biological: AGS-1C4D4
IV infusion
Biological: Gemcitabine
IV infusion

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902291

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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00902291     History of Changes
Other Study ID Numbers: 2008002, 2009-009194-99
Study First Received: May 13, 2009
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:
Clinical Trial, Phase II
Combination Drug Therapy
Gemcitabine
AGS-1C4D4
Pancreatic Cancer

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

ClinicalTrials.gov processed this record on October 21, 2014