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

MediGene212 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

Adenocarcinoma Metastasis Pancreas Neoplasms

Interventions

Gemcitabine aloneDRUG

Gemcitabine monotherapy 1000 mg/m2 weekly

EndoTAG-1 and GemcitabineDRUG

EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

EndoTAG-1 and GemcitabineDRUG

EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Prague, Czechia

Unnamed facility

Budapest, Hungary

Unnamed facility

Kiev, Ukraine

Outcomes

Primary Outcomes

Progression free survival

Time frame: Median

6-month-survival-rate

Time frame: 6 Months

Overall survival

Time frame: Median

Secondary Outcomes

Incidence and percentage of patients with Adverse Events

Time frame: 28 days after last patient out

Number of clinically significant abnormal laboratory values

Time frame: Last patient out

Data from ClinicalTrials.gov

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