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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
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
Details
| Lead sponsor | MediGene |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 212 |
| Start date | 2005-09 |
| Completion | 2008-10 |
Conditions
- Adenocarcinoma
- Metastasis
- Pancreas Neoplasms
Interventions
- Gemcitabine alone
- EndoTAG-1 and Gemcitabine
- EndoTAG-1 and Gemcitabine
- EndoTAG-1 and Gemcitabine
Primary outcomes
- Progression free survival — Median
- 6-month-survival-rate — 6 Months
- Overall survival — Median
Countries
Czechia, Hungary, Ukraine