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.

• Conditions: C25; Malignant neoplasm of pancreas

• Registration Number: DRKS00006805
• Lead Sponsor: ClinAssess GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-10
• Study Completion: 2020-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary endpoint:<br>- progression free survival (PFS)<br> (evaluation according to local standard)

Secondary Outcome Measures

Name	Time	Method
- efficacy<br>- time to progression (TTP)<br>- disease control rate (DCR)<br>- overal survival (OS)<br>- safety<br>- toxicity (NCI-CTC 4.0)<br>- dosage and application<br>- treatment interruption and reasons for interruption<br>- end of treatment and reasons for termination<br>- dose modification and reasons for modification