Pancreatic Cancer Research

Clinical trialObsCompleted

Treatment of Pancreatic Cancer With Abraxane

Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients

NCT02555813↗ ClinicalTrials.gov, retrieved 5 November 2026

Outcome
Finished, no results posted
Phase
Obs
Status
Completed
Study type
Observational
Start
8 May 2015
Expected end
7 September 2020
Enrollment
317 participants
Sites
19
Primary outcomes
Number of participants with adverse events
Sponsor
Industry
Results posted
No
Last update
19 October 2020

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Drug: Abraxane. Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity

Intervention public domain (ClinicalTrials.gov)

Drug: Gemcitabine. Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity

Arm public domain (ClinicalTrials.gov)

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

Primary outcome public domain (ClinicalTrials.gov)

Number of participants with adverse events. 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. Time frame: Up to 5 years.

Secondary outcome public domain (ClinicalTrials.gov)

Best Overall Response. Time frame: Up to 5 years.

Eligibility public domain (ClinicalTrials.gov)

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 \-

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 317 participants (actual).

Papers 9