An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Antibody Levels
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.
Time frame: Up to Week 24
Injection Site Reaction
An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
Time frame: Up to Week 12
World Health Organization (WHO) Performance Status
WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Time frame: Up to Week 12
Diptheria Toxoid Antibody Levels
Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
Time frame: Up to Week 12
Adverse Events
Any adverse events that were reported during the study
Time frame: Up to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.