Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer (GC5)
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|ClinicalTrials.gov Identifier: NCT02450032|
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Biological: G17DT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Multi-center Study to Determine the Antibody Response to 500µg G17DT Given at Weeks 0, 2, and 6 in the Treatment of Patients With Gastric Cancer|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||May 2001|
Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
Other Name: Polyclonal Antibody Stimulator
- Antibody Levels [ Time Frame: Through Week 12 ]Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.
- Injection Site Reaction [ Time Frame: Up to Week 12 ]A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
- Change in Subject's World Health Organization Performance Status [ Time Frame: Through Week 12 ]The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.
- Overall Survival [ Time Frame: From date of randomization up to Week 24 or until death ]Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.
- Adverse Events [ Time Frame: Through week 12 ]All adverse events reported during the study.
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): NCT02450032
|Glasgow Royal Infirmary|
|Glasgow, United Kingdom, G31 2 ER|
|Principal Investigator:||Robert Stuart, MB ChB||Glasgow Royal Infirmary|