NCT00044031

Brief Summary

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3 pancreatic-cancer

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

Study Start

First participant enrolled

February 1, 2001

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

August 16, 2002

Last Update Submit

April 16, 2014

Conditions

Pancreatic Cancer

Keywords

pancreatic cancerG17DTgemcitabine

Outcome Measures

Primary Outcomes (1)

  • Survival

    Up to 12 months

Secondary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    Up to 12 months

Study Arms (2)

B

PLACEBO COMPARATOR

Placebo (immunogen vehicle) combined with gemcitabine.

A

EXPERIMENTAL

500 µg G17DT immunogen combined with gemcitabine.

Biological: G17DT Immunogen

Interventions

G17DT ImmunogenBIOLOGICAL
A

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
  • Life expectancy of at least 3 months
  • Functional status by Karnofsky Index of at least 70

You may not qualify if:

  • Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
  • Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
  • Immunodeficiency
  • Bone marrow transplant within past year
  • Brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

gastrin immunogen

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • R Hawkins, M.D.

    Christie Hospital, Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

August 16, 2002

First Posted

August 20, 2002

Study Start

February 1, 2001

Primary Completion

April 1, 2004

Study Completion

October 1, 2007

Last Updated

April 17, 2014

Record last verified: 2014-04