- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00245362
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
October 27, 2005 updated by: Cell Genesys
To evaluate the safety and effectiveness of CG8020 and CG2505.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States
- Johns Hopkins University School of Medicine
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Texas
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Dallas, Texas, United States
- US Oncology
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
- Chemotherapy naïve or chemotherapy experienced pancreatic cancer
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Overall survival
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Safety
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Efficacy measured by clinical benefit response
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Progression-free survivial
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
June 1, 2002
Study Completion
June 1, 2004
Study Registration Dates
First Submitted
October 27, 2005
First Submitted That Met QC Criteria
October 27, 2005
First Posted (Estimate)
October 28, 2005
Study Record Updates
Last Update Posted (Estimate)
October 28, 2005
Last Update Submitted That Met QC Criteria
October 27, 2005
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of LeipzigCompletedCardiac Arrest | HypothermiaGermany
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Universidad de CórdobaUnknown
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Fundación Pública Andaluza para la Investigación...University of MalagaUnknownDepression | Type 1 Diabetes MellitusSpain