Treatment of Pancreatic Cancer With Abraxane

Celgene

Status: Completed

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Abraxane; Drug: Gemcitabine

Study type: Observational

Funder types: Industry

Identifiers

NCT02555813

ABI-007-PANC-006

Details and patient eligibility

About

This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

Full description

This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Metastatic pancreatic carcinoma
2. Age > 18 years
3. Signed Informed Consent
4. Normal hepatic, renal and Bone Marrow functions

Exclusion criteria

1. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils < 1,5 x 10^9/L

Trial design

317 participants in 1 patient group

Abraxane + Gemcitabine

Description:

Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression

Treatment:

Drug: Gemcitabine

Drug: Abraxane