NCT00377936

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: MediGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

Conditions

• Adenocarcinoma
• Metastasis
• Pancreas Neoplasms

Interventions

Type	Name	Description
DRUG	Gemcitabine alone	Gemcitabine monotherapy 1000 mg/m2 weekly
DRUG	EndoTAG-1 and Gemcitabine	EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
DRUG	EndoTAG-1 and Gemcitabine	EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
DRUG	EndoTAG-1 and Gemcitabine	EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2006-09-19
• Last updated: 2008-11-14

Locations

3 sites across 3 countries: Czechia, Hungary, Ukraine