Clinical trial · Interventional
An Open Label Study to Evaluate G17DT Compared to Gemcitabine
A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
NCT03200821CI-TRIAL-00028299completedPhase 3ClinicalTrials.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)
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G17DT | Biological | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G17DT
- description
- 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
- interventionNames
- Biological: G17DT
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- 1000 µg/m\^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent. * A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection. * Male or female patients over 18 years of age. * Laboratory values within the following ranges at screening: Serum creatinine \< 1.25 times upper limit of normal (ULN) Haemoglobin \> 9.5 g/dL White blood cell (WBC) count \> 3.5 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 2.0 times ULN Aspartate transaminase (AST, SGOT) \< 3 times ULN * A life expectancy of at least 2 months. * A negative pregnancy test at the screening visit (females of childbearing potential only). * Signed written informed consent. Exclusion Criteria: * History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix). * Previous cytotoxic chemotherapy (including gemcitabine). * Previous radiotherapy within 30 days of baseline. * Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted. * Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study. * Participation in another study involving an investigational drug within 90 days of baseline.
References
Publications (0)
Data not yet available
No reference posted for this study.