Clinical trial · Interventional
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
NCT02098239CI-TRIAL-00014118completedPhase 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)
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Jaundice | — | UNRESOLVED | — |
| 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 (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Jaundiced patients with bilirubin value \>80 μmol/L. Received G17DT immediately prior to biliary stenting.
- interventionNames
- Drug: G17DT
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was \<40 μmol/L.
- interventionNames
- Drug: G17DT
Primary outcomes (2)
- measure
- Pharmacodynamic
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection. * If patients were jaundiced, bilirubin had to be \>80 μmol/L. * Male or female patients over 18 years of age. * World Health Organization (WHO) performance status of 0 to 2. * Patients with a life expectancy of at least 8 weeks. * Patients must have given written informed consent. Exclusion Criteria: * Patients undergoing a potentially curative resection. * Jaundiced patients with a bilirubin value \<80 μmol/L. * Patients not considered fit for endoscopic or percutaneous biliary stenting. * Patients receiving any other anti-cancer therapy. * History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix. * Females who were pregnant, planning to become pregnant, or who were lactating. * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study. * Previous G17DT treatment. * Haematological indicators: Haemoglobin (Hb) \<10.0 g/dL. White cell count (WCC) \<4.0×109/L. Platelets \<100×109/L.
References
Publications (0)
Data not yet available
No reference posted for this study.