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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902291
• Other study ID #: 2008002
• Secondary ID: 2009-009194-99
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2009
• Last updated: August 31, 2015
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaRussia: Ministry of Health of the Russian FederationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Pancreatic Cancer
• Pancreatic Disease
• Pancreatic Diseases
• Pancreatic Neoplasms

Intervention

Biological:
• AGS-1C4D4
IV infusion
• Gemcitabine
IV infusion

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
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
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
Spain	Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia	Barcelona
Spain	Hospital Virgen de la Salud, Servicio Oncologia	Toledo
United States	Annapolis Oncology Center	Annapolis	Maryland
United States	Medical Oncology LLC	Baton Rouge	Louisiana
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Baptist Regional Cancer Center	Knoxville	Tennessee
United States	University of California San Diego Medical Center	La Jolla	California
United States	Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic	Lynchburg	Virginia
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Virginia G. Piper Cancer Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center, Div. of Medical Oncology	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Kaiser Permanente Northwest Region Oncology Hematology	Portland	Oregon
United States	Regional Oncology Center	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Agensys, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Russian Federation,  Spain, 

References & 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):1792-801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate at 6 months		6 months	No
Secondary	Overall Survival (OS)		Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study	No
Secondary	Progression free survival (PFS)		Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study	No
Secondary	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	No
Secondary	Incidence of anti-AGS-1C4D4 antibody formation		Week 1, Week 7 and every 8 weeks during the extended treatment period	No
Secondary	Objective Response Rate (Partial Response or better per RECIST criteria version 1.1		Week 8, and every 8 weeks during the extended treatment period	No
Secondary	Disease Control (Stable Disease or better per RECIST criteria)		Week 8, and every 8 weeks during the extended treatment period	No

External Links

•   Link to Results on JAPIC