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EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

NCT00377936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2008-11-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MediGene

    lead INDUSTRY

Principal Investigators

  • Matthias Löhr, Prof. · Universitätsklinikum Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-06-30
Completion
2008-10-31

Countries

  • Czechia
  • Hungary
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377936 on ClinicalTrials.gov