NCT00245362

Brief Summary

To evaluate the safety and effectiveness of CG8020 and CG2505.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

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

Study Start

First participant enrolled

June 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

October 28, 2005

Status Verified

October 1, 2005

First QC Date

October 27, 2005

Last Update Submit

October 27, 2005

Conditions

Metastatic Pancreatic CancerNonresectable Pancreatic Cancer

Keywords

cancer vaccinepancreatic cancermetastatic pancreatic cancerunresectable pancreatic cancerimmunotherapy

Outcome Measures

Primary Outcomes (4)

  • Safety

  • Efficacy measured by clinical benefit response

  • Progression-free survivial

  • Overall survival

Interventions

CG 8020 and CG 2505BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
  • Chemotherapy naïve or chemotherapy experienced pancreatic cancer

You may not qualify if:

  • Prior cancer vaccines or gene therapy
  • History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
  • History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Location

US Oncology

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

June 1, 2002

Study Completion

June 1, 2004

Last Updated

October 28, 2005

Record last verified: 2005-10

Locations

US(2)