A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
2 other identifiers
interventional
205
5 countries
36
Brief Summary
A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 14, 2015
August 1, 2015
3 years
May 13, 2009
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate at 6 months
6 months
Secondary Outcomes (6)
Overall Survival (OS)
Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study
Progression free survival (PFS)
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
Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period
Incidence of anti-AGS-1C4D4 antibody formation
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
Week 8, and every 8 weeks during the extended treatment period
- +1 more secondary outcomes
Study Arms (2)
1. Gemcitabine monotherapy
ACTIVE COMPARATOR2. Gemcitabine plus AGS-1C4D4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Agensys, Inc.collaborator
Study Sites (36)
University of California San Diego Medical Center
La Jolla, California, 92093, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
University of Miami
Miami, Florida, 33136, United States
Medical Oncology LLC
Baton Rouge, Louisiana, 70809, United States
Annapolis Oncology Center
Annapolis, Maryland, 21401, United States
Dana Farber Cancer Center
Boston, Massachusetts, 02115, United States
Virginia G. Piper Cancer Center
Minneapolis, Minnesota, 55407, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Regional Oncology Center
Syracuse, New York, 13210, United States
Kaiser Permanente Northwest Region Oncology Hematology
Portland, Oregon, 97227, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920, United States
Vanderbilt University Medical Center, Div. of Medical Oncology
Nashville, Tennessee, 37232, United States
Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Chu Estaing
Clermont-Ferrand, France
Centre Jean Bernard, Oncologie médicale
Le Mans, 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, France
Hôpital Charles Nicolle
Rouen, France
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Russia
Regional Oncology Dispensary
Ivanovo, Russia
Clinical Oncology Dispensary of Republic of Tatarstan
Kazan', Russia
State Healthcare Institution "Leningrad Regional Oncologic Dispensary"
Kuzmolovo, Russia
Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"
Moscow, Russia
Medical Radiology Research Center of Russian Medical Academy
Obninsk, Russia
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
Omsk, Russia
Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"
Saint Petersburg, Russia
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
Saint Petersburg, Russia
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
Barcelona, Spain
Unknown Facility
Madrid, Spain
Hospital Virgen de la Salud, Servicio Oncologia
Toledo, Spain
Related Publications (1)
Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-1801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.
PMID: 23448807BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Agensys, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 14, 2015
Record last verified: 2015-08