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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006805 |
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Date of registration:
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10/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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- EffiXane - Non-interventional study of the safety and efficacy of nab-paclitaxel (Abraxane®) + Gemcitabine in the first line treatment of metastatic adenocarcinoma of the pancreas.
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Scientific title:
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- EffiXane - Non-interventional study of the safety and efficacy of nab-paclitaxel (Abraxane®) + Gemcitabine in the first line treatment of metastatic adenocarcinoma of the pancreas. - EffiXane |
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Date of first enrolment:
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08/12/2014 |
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Target sample size:
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200 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006805 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Ralf-Bodo
Kühn |
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Address:
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Grüne Str. 11
26121
Oldenburg
Germany |
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Telephone:
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0441 7705980 |
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Email:
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info@onkopraxis-oldenburg.de |
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Affiliation:
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Facharzt für Innere Medizin, Hämatologie und OnkologieOnkologische Praxis OldenburgDrs. Otremba, Rescheke, Zirpel und Kühn |
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Name:
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Burkhard
Deuß |
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Address:
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Birkenbergstr. 82
51379
Leverkusen
Germany |
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Telephone:
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02171 363360 |
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Email:
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info@clinassess.de |
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Affiliation:
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ClinAssess GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: - metatstatic pancreatic carcinoma
- medicinal decision for tretament with Abraxane/ Gemicitabin before and independent of inclusion into the non-interventionel study
- = age 18 years
- written informed consent
Exclusion criteria: • neutrophil count < 1,5 x 109/l
• hypersensitivity to (nab-Paclitaxel) or any other compound: humanserumalbumin (Sodium, sodium caprylate und N-Acetyltryptophanate)
• hypersensitivity to Gemcitabin or any other compound of Gemcitabin
• Pregnant or lactating females
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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C25
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Malignant neoplasm of pancreas
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Intervention(s)
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Group 1: Abraxane (nab-Paclicatel) + Gemcitabine treatment according to marketing authorization administered as part of routine clinical practice
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Primary Outcome(s)
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primary endpoint:
- progression free survival (PFS)
(evaluation according to local standard)
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Secondary Outcome(s)
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- efficacy
- time to progression (TTP)
- disease control rate (DCR)
- overal survival (OS)
- safety
- toxicity (NCI-CTC 4.0)
- dosage and application
- treatment interruption and reasons for interruption
- end of treatment and reasons for termination
- dose modification and reasons for modification
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Source(s) of Monetary Support
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Celgene GmbH
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Ethics review
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Status: Approved
Approval date: 08/09/2014
Contact:
ethikkommission@aekn.de
Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen
+49-511-3802208
ethikkommission@aekn.de
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