Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02518529|
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Cancer Advances Inc.
Information provided by (Responsible Party):
Cancer Advances Inc.
Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Biological: G17DT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
Experimental: 250µg dose treatment
Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
Other Name: Gastrimmune, Insegia, PAS
Primary Outcome Measures :
- Measurable Gastrin-17 Antibody Titer [ Time Frame: Up to Week 52 ]
Secondary Outcome Measures :
- Injection tolerability [ Time Frame: Up to Week 52 ]Subjects were monitored for injection site reactions and/or swelling at the injections site.
- Overall Survival from date of randomization to death or end of study [ Time Frame: Up to December 2002 ]
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