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 |
| ClinicalTrials.gov (NCT) | NCT00377936 |
| Clinical Trials Information System (CTIS) | 2005-000666-39 |
| Protocol serial number | CT4001 |
| Sponsor | MediGene AG (Germany) |
| Funder | MediGene AG (Germany) |
- 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
Contact information
Prof Matthias Lohr
Scientific
Scientific
Universitätsklinikum Mannheim
II. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
| matthias.loehr@med.ma.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Controlled, randomized, open label, phase II trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | EndoTAG®-1 (lipid-complexed paclitaxel Gemcitabine |
| Primary outcome measure(s) |
1. Median overall survival |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
68167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
