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Treatment of Pancreatic Cancer With Abraxane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02555813
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer Drug: Abraxane Drug: Gemcitabine

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.

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Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
Abraxane + Gemcitabine
Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression
Drug: Abraxane
Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity
Other Names:
  • Nab-paclitaxel
  • ABI-007

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

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Metastatic pancreatic cancer

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


Information from the National Library of Medicine

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 identifier (NCT number): NCT02555813

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Sponsors and Collaborators
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Study Chair: Guenter Voraberger, MD Celgene Austria

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Responsible Party: Celgene Identifier: NCT02555813    
Other Study ID Numbers: ABI-007-PANC-006
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Celgene:
Metastatic Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Albumin-Bound Paclitaxel
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs