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
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