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

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

Study information

Study designControlled, randomized, open label, phase II trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
Study objectivesEvaluation 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) studiedLocally advanced and/or metastatic adenocarcinoma of the pancreas
InterventionCombination therapy of EndoTAG®-1 (lipid-complexed paclitaxel) and gemcitabine with three different doses of EndoTAG®-1 compared to gemcitabine monotherapy
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)EndoTAG®-1 (lipid-complexed paclitaxel Gemcitabine
Primary outcome measure1. Median overall survival
2. Median time to progression
3. Response rate
4. Clinical benefit
5. Adverse events
Secondary outcome measuresNot provided at time of registration
Overall study start date26/09/2005
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants200
Total final enrolment212
Key inclusion criteria1. Inoperable adenocarcinoma of the pancreas
2. Histological confirmation
3. At least 18 years of age
Key exclusion criteria1. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
2. Major surgery within four weeks prior to enrolment
3. Major cardiovascular disease
Date of first enrolment26/09/2005
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Universitätsklinikum Mannheim
Mannheim
68167
Germany

Sponsor information

Funders

Funder type

Industry

MediGene AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.

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