Clinical trial · Interventional
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
- 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 intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoTAG-1 and Gemcitabine | Drug | — | UNRESOLVED |
| Gemcitabine alone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Gemcitabine
- interventionNames
- Drug: Gemcitabine alone
- type
- EXPERIMENTAL
- label
- 2
- description
- EndoTag-1 + Gemcitabine
- interventionNames
- Drug: EndoTAG-1 and Gemcitabine
- type
- EXPERIMENTAL
- label
- 3
- description
- EndoTag-1 + Gemcitabine
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable adenocarcinoma of the pancreas * Histologic or cytologic confirmation * At least 18 years of age Exclusion Criteria: * Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment * Major surgery within 4 weeks prior to enrollment * Major cardiovascular disease
References
Publications (0)
Data not yet available