A Study Of AGS-1C4D4 Given In Combination With Gemcitabine In Subjects With Metastatic Pancreatic Cancer

Study Overview

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

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

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.

Carcinoma, Pancreatic Ductal
Pancreatic Cancer
Pancreatic Disease

BIOLOGICAL: AGS-1C4D4
BIOLOGICAL: Gemcitabine

2008002
2009-009194-99 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-08-31
First Submitted that Met QC Criteria 2009-05-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-14
First Posted (ESTIMATED) 2009-05-15	Results First Posted N/A	Last Verified 2015-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1. Gemcitabine monotherapy	BIOLOGICAL: Gemcitabine IV infusion
EXPERIMENTAL: 2. Gemcitabine plus AGS-1C4D4	BIOLOGICAL: AGS-1C4D4 IV infusion BIOLOGICAL: Gemcitabine IV infusion

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 1. Gemcitabine monotherapy

BIOLOGICAL: Gemcitabine

IV infusion

EXPERIMENTAL: 2. Gemcitabine plus AGS-1C4D4

BIOLOGICAL: AGS-1C4D4

IV infusion

BIOLOGICAL: Gemcitabine

IV infusion

Primary Outcome Measures	Measure Description	Time Frame
Survival rate at 6 months		6 months

Secondary Outcome Measures	Measure Description	Time Frame
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
Disease Control (Stable Disease or better per RECIST criteria)		Week 8, and every 8 weeks during the extended treatment period

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Agensys, Inc.

Investigators

STUDY_DIRECTOR: Chief Medical Officer, Agensys, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Resources

PatientS

Caregivers

Clinical Trial Record