Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
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|ClinicalTrials.gov Identifier: NCT00044031|
Recruitment Status : Completed
First Posted : August 20, 2002
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: G17DT Immunogen||Phase 3|
Expanded Access : Cancer Advances Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||394 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||October 2007|
Placebo Comparator: B
Placebo (immunogen vehicle) combined with gemcitabine.
500 µg G17DT immunogen combined with gemcitabine.
Biological: G17DT Immunogen
- Survival [ Time Frame: Up to 12 months ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 12 months ]Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044031
|Principal Investigator:||R Hawkins, M.D.||Christie Hospital, Manchester|