Treatment of Pancreatic Cancer With Abraxane
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|ClinicalTrials.gov Identifier: NCT02555813|
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment|
|Metastatic Pancreatic Cancer||Drug: Abraxane Drug: Gemcitabine|
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.
|Study Type :||Observational|
|Actual Enrollment :||317 participants|
|Official Title:||Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients|
|Actual Study Start Date :||May 8, 2015|
|Actual Primary Completion Date :||September 7, 2020|
|Actual Study Completion Date :||September 7, 2020|
Abraxane + Gemcitabine
Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression
Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity
Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity
Other Name: Gemzar
- 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.
- Best Overall Response [ Time Frame: Up to 5 years ]Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555813
|Study Chair:||Guenter Voraberger, MD||Celgene Austria|