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

NCT ID: NCT00902291

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

Brief Summary

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

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.

Conditions

Carcinoma, Pancreatic Ductal; Pancreatic Cancer; Pancreatic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. Gemcitabine monotherapy

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: BIOLOGICAL

IV infusion

2. Gemcitabine plus AGS-1C4D4

Group Type: EXPERIMENTAL

AGS-1C4D4

Intervention Type: BIOLOGICAL

IV infusion

Gemcitabine

Intervention Type: BIOLOGICAL

IV infusion

Interventions

AGS-1C4D4

IV infusion

Intervention Type: BIOLOGICAL

Gemcitabine

IV infusion

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agensys, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Agensys, Inc.

Locations

University of California San Diego Medical Center

La Jolla, California, United States

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, United States

University of Miami

Miami, Florida, United States

Medical Oncology LLC

Baton Rouge, Louisiana, United States

Annapolis Oncology Center

Annapolis, Maryland, United States

Dana Farber Cancer Center

Boston, Massachusetts, United States

Virginia G. Piper Cancer Center

Minneapolis, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Regional Oncology Center

Syracuse, New York, United States

Kaiser Permanente Northwest Region Oncology Hematology

Portland, Oregon, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Baptist Regional Cancer Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center, Div. of Medical Oncology

Nashville, Tennessee, United States

Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic

Lynchburg, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, 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

Madrid, , Spain

Hospital Virgen de la Salud, Servicio Oncologia

Toledo, , Spain

Countries

United States; Canada; France; Russia; Spain

References

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.

Reference Type: BACKGROUND

PMID: 23448807 (View on PubMed)

Other Identifiers

2009-009194-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2008002

Identifier Type: -

Identifier Source: org_study_id