Clinical trial · Interventional
An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
NCT02098291CI-TRIAL-00014130PC1completedPhase 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 determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G17DT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- G17DT
- interventionNames
- Drug: G17DT
Primary outcomes (1)
- measure
- Pharmacodynamic
- timeFrame
- Up to week 16
- description
- Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
Secondary outcomes (2)
- measure
- Patient Survival
- timeFrame
- Up to week 139
- description
- The vital status was monitored throughout the study and was followed up to the death of the last patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent * Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study * Male or female patients over 18 years of age * Patients with a life expectancy of at least 2 months * Patients must have given written informed consent * Patients with a Karnofsky Performance Status score of ≥ 50% * Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study) Exclusion Criteria: * History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix * Concomitant use or anticipated use in the period of the study of radiotherapy * Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study * Use in the past month or 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 enrolment or during the study * Haematological indicators: Haemoglobin \<9.5g/dl White blood cell count \<3.5 x 109/l Platelets \<100 x 109/l
References
Publications (0)
Data not yet available
No reference posted for this study.