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

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:

Genetics Home Reference related topics: Aicardi-Goutieres syndrome

MedlinePlus related topics: Cancer Pancreatic Cancer Pancreatic Diseases

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

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

Show 36 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Agensys, Inc.

Investigators

Study Director:

Chief Medical Officer

Agensys, Inc.

More Information

No publications provided

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:	July 23, 2012
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:

Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Carcinoma
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013