A Phase II Trial Of CG 8020 And CG 2505 In Patients With Nonresectable Or Metastatic Pancreatic Cancer

Study Overview

A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

To evaluate the safety and effectiveness of CG8020 and CG2505.

To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Metastatic Pancreatic Cancer
Nonresectable Pancreatic Cancer

BIOLOGICAL: CG 8020 and CG 2505

P-0011

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 2005-10-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2005-10-27
First Submitted that Met QC Criteria 2005-10-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2005-10-28
First Posted (ESTIMATED) 2005-10-28	Results First Posted N/A	Last Verified 2005-10

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:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Safety
Efficacy measured by clinical benefit response
Progression-free survivial
Overall survival

Secondary Outcome Measures	Measure Description	Time Frame

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:

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

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

Collaborators and Investigators

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

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

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record