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OpenTrials
Completed

NCT Number: NCT02555813

Treatment of Pancreatic Cancer With Abraxane

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.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BHB Eisenstadt, Eisenstadt, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic pancreatic carcinoma
  • Age > 18 years
  • Signed Informed Consent
  • Normal hepatic, renal and Bone Marrow functions

Exclusion criteria

  • 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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Treatment and study plan

Abraxane

Drug

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

Other names: Nab-paclitaxel, ABI-007

Gemcitabine

Drug

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

Other names: Gemzar

Primary outcomes

  1. 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

  1. 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).

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 22, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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