Clinical trial · Interventional
Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer
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
NCT02450032CI-TRIAL-00017980GC5completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G17DT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- G17DT
- description
- Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
- interventionNames
- Biological: G17DT
Primary outcomes (3)
- measure
- Antibody Levels
- timeFrame
- Through Week 12
- description
- 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.
- measure
- Injection Site Reaction
- timeFrame
- Up to Week 12
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. * Patients must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial. * Male or Female patients aged 18 years or older. * Life expectancy of at least 3 months. * WHO Performance Status of 0 to 1. * Written informed consent Exclusion Criteria: * Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study. * History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix. * Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies. * Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids. * Females who were pregnant, planning to become pregnant or lactating. * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study. * Previous G17DT treatment. * Haematologicial indicators: Haemoglobin (Hb) \< 10g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L
References
Publications (0)
Data not yet available
No reference posted for this study.