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

NCT ID: NCT00377936

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Adenocarcinoma Metastasis Pancreas Neoplasms

Keywords

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Adenocarcinoma of the pancreas Locally advanced Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gemcitabine

Group Type ACTIVE_COMPARATOR

Gemcitabine alone

Intervention Type DRUG

Gemcitabine monotherapy 1000 mg/m2 weekly

2

EndoTag-1 + Gemcitabine

Group Type EXPERIMENTAL

EndoTAG-1 and Gemcitabine

Intervention Type DRUG

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

3

EndoTag-1 + Gemcitabine

Group Type EXPERIMENTAL

EndoTAG-1 and Gemcitabine

Intervention Type DRUG

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

4

EndoTag-1 + Gemcitabine

Group Type EXPERIMENTAL

EndoTAG-1 and Gemcitabine

Intervention Type DRUG

EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Interventions

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Gemcitabine alone

Gemcitabine monotherapy 1000 mg/m2 weekly

Intervention Type DRUG

EndoTAG-1 and Gemcitabine

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

Intervention Type DRUG

EndoTAG-1 and Gemcitabine

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

Intervention Type DRUG

EndoTAG-1 and Gemcitabine

EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MediGene

INDUSTRY

Sponsor Role lead

Responsible Party

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MediGene

Principal Investigators

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Matthias Löhr, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Mannheim

Locations

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Prague, , Czechia

Site Status

Budapest, , Hungary

Site Status

Kiev, , Ukraine

Site Status

Countries

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Germany Sweden Czechia Hungary Ukraine

Other Identifiers

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EudraCT No.: 2005-000666-39

Identifier Type: -

Identifier Source: secondary_id

CT4001

Identifier Type: -

Identifier Source: org_study_id