EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

ISRCTN	ISRCTN24531831
DOI	https://doi.org/10.1186/ISRCTN24531831
EudraCT/CTIS number	2005-000666-39
ClinicalTrials.gov number	NCT00377936
Secondary identifying numbers	CT4001

Submission date: 19/01/2006
Registration date: 02/03/2006
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Matthias Lohr
Scientific

Universitätsklinikum Mannheim
II. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email	matthias.loehr@med.ma.uni-heidelberg.de

Study information

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
Scientific title	EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Total final enrolment	212
Key inclusion criteria	1. Inoperable adenocarcinoma of the pancreas 2. Histological confirmation 3. At least 18 years of age
Key exclusion criteria	1. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment 2. Major surgery within four weeks prior to enrolment 3. Major cardiovascular disease
Date of first enrolment	26/09/2005
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

Germany

Study participating centre

Universitätsklinikum Mannheim

Mannheim
68167
Germany

Sponsor information

MediGene AG (Germany)
Industry

Lochhamer Str. 11
Planegg
82152
Germany

Email	u.schoenherr@medigene.com
Website	http://www.medigene.com
"ROR"	https://ror.org/03kkjyc12

Funders

Funder type

Industry

MediGene AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012	11/01/2021	Yes	No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT and EudraCT numbers have been added.