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Register:	ISRCTN
Last refreshed on:	25 January 2021
Main ID:	ISRCTN24531831
Date of registration:	02/03/2006
Prospective Registration:	No
Primary sponsor:	MediGene AG (Germany)
Public title:	EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Scientific title:	EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Date of first enrolment:	26/09/2005
Target sample size:	200
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN24531831
Study type:	Interventional
Study design:	Controlled, randomized, open label, phase II trial (Treatment)
Phase:	Phase II

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Matthias Lohr
Address:	Universitätsklinikum Mannheim II. Medizinische Klinik Theodor-Kutzer-Ufer 1-3 68167 Mannheim Germany
Telephone:	-
Email:	matthias.loehr@med.ma.uni-heidelberg.de
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Inoperable adenocarcinoma of the pancreas
2. Histological confirmation
3. At least 18 years of age

Exclusion criteria:
1. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
2. Major surgery within four weeks prior to enrolment
3. Major cardiovascular disease

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Locally advanced and/or metastatic adenocarcinoma of the pancreas
Cancer
Locally advanced and/or metastatic adenocarcinoma of the pancreas

Intervention(s)

Combination therapy of EndoTAG®-1 (lipid-complexed paclitaxel) and gemcitabine with three different doses of EndoTAG®-1 compared to gemcitabine monotherapy

Primary Outcome(s)

1. Median overall survival
2. Median time to progression
3. Response rate
4. Clinical benefit
5. Adverse events

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

NCT00377936

CT4001

2005-000666-39

Source(s) of Monetary Support

MediGene AG (Germany)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Medical Ethics Commission II, Faculty for Clinical Medicine Mannheim, Ruprecht-Karls University of Heidelberg, registration number 91/05

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/2007
URL:

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