EndoTAG-1 / Gemcitabine Combination Therapy To Treat Locally Advanced And/or Metastatic Adenocarcinoma Of The Pancreas

Study Overview

EndoTAG-1 / Gemcitabine Combination Therapy to Treat 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.

N/A

Adenocarcinoma
Metastasis
Pancreas Neoplasms

DRUG: Gemcitabine alone
DRUG: EndoTAG-1 and Gemcitabine
DRUG: EndoTAG-1 and Gemcitabine
DRUG: EndoTAG-1 and Gemcitabine

CT4001
EudraCT No.: 2005-000666-39

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-09-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-11-13
First Submitted that Met QC Criteria 2006-09-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-11-14
First Posted (ESTIMATED) 2006-09-19	Results First Posted N/A	Last Verified 2008-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1 Gemcitabine	DRUG: Gemcitabine alone Gemcitabine monotherapy 1000 mg/m2 weekly
EXPERIMENTAL: 2 EndoTag-1 + Gemcitabine	DRUG: EndoTAG-1 and Gemcitabine EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EXPERIMENTAL: 3 EndoTag-1 + Gemcitabine	DRUG: EndoTAG-1 and Gemcitabine EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EXPERIMENTAL: 4 EndoTag-1 + Gemcitabine	DRUG: EndoTAG-1 and Gemcitabine EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival		Median
6-month-survival-rate		6 Months
Overall survival		Median

Secondary Outcome Measures	Measure Description	Time Frame
Incidence and percentage of patients with Adverse Events		28 days after last patient out
Number of clinically significant abnormal laboratory values		Last patient out

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Inoperable adenocarcinoma of the pancreas
Histologic or cytologic confirmation
At least 18 years of age

Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
Major surgery within 4 weeks prior to enrollment
Major cardiovascular disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Matthias Löhr, Prof., Universitätsklinikum Mannheim

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record