Condition category
Cancer
Date applied
19/01/2006
Date assigned
02/03/2006
Last edited
02/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medigene.com

Contact information

Type

Scientific

Primary contact

Prof Matthias Lohr

ORCID ID

Contact details

Universitätsklinikum Mannheim
II. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
matthias.loehr@med.ma.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT4001

Study information

Scientific title

Acronym

Study hypothesis

Evaluation of safety and efficacy of the combination treatment versus gemcitabine monotherapy

Ethics approval

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

Study design

Controlled, randomized, open label, phase II trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Locally advanced and/or metastatic adenocarcinoma of the pancreas

Intervention

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

Intervention type

Drug

Phase

Phase II

Drug names

EndoTAG®-1 (lipid-complexed paclitaxel
Gemcitabine

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/09/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

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

Recruitment start date

26/09/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Mannheim
Mannheim
68167
Germany

Sponsor information

Organisation

MediGene AG (Germany)

Sponsor details

Lochhamer Str. 11
Planegg
82152
Germany
u.schoenherr@medigene.com

Sponsor type

Industry

Website

http://www.medigene.com

Funders

Funder type

Industry

Funder name

MediGene AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes