NCT01608711

Brief Summary

The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Aug 2012

Geographic Reach
2 countries

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 7, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2015

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

May 29, 2012

Last Update Submit

May 15, 2017

Conditions

Pancreatic CancerCarcinoma, Pancreatic DuctalPancreatic Disease

Keywords

GemcitabineASP6182AGS-1C4D4Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

    Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4

    31 months

  • Incidence of anti-AGS-1C4D4 antibody formation

    Every 8 weeks (up to 31 months)

Study Arms (1)

AGS-1C4D4 plus gemcitabine

EXPERIMENTAL

Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.

Biological: AGS-1C4D4Biological: gemcitabine

Interventions

AGS-1C4D4BIOLOGICAL

Intravenous Infusion

Also known as: ASP6182
AGS-1C4D4 plus gemcitabine
gemcitabineBIOLOGICAL

Intravenous Infusion

AGS-1C4D4 plus gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002

You may not qualify if:

  • More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
  • Use of the following prohibited medications / therapies:
  • Monoclonal antibody therapy, other than AGS-1C4D4
  • Chemotherapy, other than gemcitabine
  • Investigational therapy other than AGS-1C4D4
  • Erlotinib (Tarceva)
  • Any clinical condition which would not allow safe conduct of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site US116

Madison, Wisconsin, 53226, United States

Location

Site CA00203

Toronto, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinoma, Pancreatic DuctalPancreatic Diseases

Interventions

MK-4721Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Agensys, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

August 7, 2012

Primary Completion

November 16, 2015

Study Completion

November 16, 2015

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

CA(1)US(1)