Clinical trial NCT02555813: Treatment of Pancreatic Cancer With Abraxane
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Pancreatic Cancer
Keywords: Metastatic Pancreatic Cancer
nab-Paclitaxel
Gemcitabine
Non-interventional
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic pancreatic cancer

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 5 years
Secondary outcomes:
measure: Best Overall Response
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Eisenstadt
country: Austria
facility: BHB Eisenstadt
city: Feldkirch
country: Austria
facility: LKH Feldkirch
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Klagenfurt
country: Austria
facility: KH Elisabethinen Klagenfurt
city: Klagenfurt
country: Austria
facility: LKH Klagenfurt
city: Krems
country: Austria
facility: KH Krems
city: Leoben
country: Austria
facility: LKH Leoben
city: Linz
country: Austria
facility: KH Barmherzige Schwestern Linz
city: Salzburg
country: Austria
facility: LKH Salzburg
city: St. Pölten
country: Austria
facility: LKH St. Pölten
city: Steyr
country: Austria
facility: LKH Steyr
city: Vienna
country: Austria
facility: Medical University Vienna
city: Vienna
country: Austria
facility: KH St. Josephs
city: Vienna
country: Austria
facility: KH Hanusch
city: Vöcklabruck
country: Austria
facility: LKH Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels
city: Wr. Neustadt
country: Austria
facility: LKH Wr. Neustadt
city: Zams
country: Austria
facility: KH Zams
Study officials:
affiliation: Celgene Austria
name: Guenter Voraberger, MD
role: STUDY_CHAIR
References:
citation: McBride A, Bonafede M, Cai Q, Princic N, Tran O, Pelletier C, Parisi M, Patel M. Comparison of treatment patterns and economic outcomes among metastatic pancreatic cancer patients initiated on nab-paclitaxel plus gemcitabine versus FOLFIRINOX. Expert Rev Clin Pharmacol. 2017 Oct;10(10):1153-1160. doi: 10.1080/17512433.2017.1365598. Epub 2017 Aug 21.
citation: Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12.
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