Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Abraxane
- Conditions
- Metastatic Pancreatic Cancer
- Sponsor
- Celgene
- Enrollment
- 317
- Locations
- 19
- Primary Endpoint
- Number of participants with adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Metastatic pancreatic carcinoma
- •Age \> 18 years
- •Signed Informed Consent
- •Normal hepatic, renal and Bone Marrow functions
Exclusion Criteria
- •Pregnant and lactating females
- •Previous treatment for metastatic pancreatic disease
- •Known hypersensitivity to nab-paclitaxel
- •Neutrophils \< 1,5 x 10\^9/L
Arms & Interventions
Abraxane + Gemcitabine
Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression
Intervention: Abraxane
Abraxane + Gemcitabine
Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: Up to 5 years
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology.
Secondary Outcomes
- Best Overall Response(Up to 5 years)