- 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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006805

Enrollment

200

Registered

2014-10-10

Start date

2014-12-08

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C25

Interventions

Group 1: Abraxane (nab-Paclicatel) + Gemcitabine treatment according to marketing authorization administered as part of routine clinical practice

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
primary endpoint: - progression free survival (PFS) (evaluation according to local standard)	—

Secondary

Measure	Time frame
- 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	—

Countries

Germany

Contacts

Public ContactBurkhard Deuß

ClinAssess GmbH

info@clinassess.de02171 363360

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026