Metastatic Pancreatic Cancer
Conditions
Keywords
Metastatic Pancreatic Cancer, nab-Paclitaxel, Gemcitabine, Non-interventional
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.
Interventions
DRUGAbraxane
Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity
DRUGGemcitabine
Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | Up to 5 years | Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR). |
Countries
Austria
Outcome results
None listed