Contact information
Type
Scientific
Contact name
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/CTIS number
2005-000666-39
IRAS number
ClinicalTrials.gov number
NCT00377936
Protocol/serial number
CT4001
Study information
Scientific title
EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Acronym
Study hypothesis
Evaluation of safety and efficacy of the combination treatment versus gemcitabine monotherapy
Ethics approval(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
EndoTAG®-1 (lipid-complexed paclitaxel
Gemcitabine
Primary outcome measure
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 study start date
26/09/2005
Overall study end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Inoperable adenocarcinoma of the pancreas
2. Histological confirmation
3. At least 18 years of age
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
200
Total final enrolment
212
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | 11/01/2021 | Yes | No |