ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02555813
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Study Type : Observational
Estimated Enrollment : 75 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
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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, and 15 until progression or toxicity
Other Names:
  • Nab-paclitaxel
  • ABI-007

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




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 3 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 3 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.


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
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


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 ClinicalTrials.gov identifier (NCT number): NCT02555813


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Austria
BHB Eisenstadt Recruiting
Eisenstadt, Austria, 7001
LKH Feldkirch Recruiting
Feldkirch, Austria, 6800:
Medical University Graz Recruiting
Graz, Austria, 8010
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020:
KH Elisabethinen Klagenfurt Recruiting
Klagenfurt, Austria, 9020
LKH Klagenfurt Recruiting
Klagenfurt, Austria, 9020
KH Krems Recruiting
Krems, Austria, 3500
LKH Leoben Enrolling by invitation
Leoben, Austria, 8700:
KH Barmherzige Schwestern Linz Recruiting
Linz, Austria, 4020:
LKH Salzburg Recruiting
Salzburg, Austria, 5020:
LKH St. Pölten Recruiting
St. Pölten, Austria, 3100:
LKH Steyr Recruiting
Steyr, Austria, 4400:
Medical University Vienna Recruiting
Vienna, Austria, 1090:
KH St. Josephs Recruiting
Vienna, Austria, 1130
KH Hanusch Recruiting
Vienna, Austria, 1140
KH SMZ Ost Completed
Vienna, Austria, 1220:
LKH Vöcklabruck Recruiting
Vöcklabruck, Austria, 4840:
Klinikum Wels Recruiting
Wels, Austria, 4600:
LKH Wr. Neustadt Recruiting
Wr. Neustadt, Austria, 2700:
KH Zams Recruiting
Zams, Austria, 6511
Sponsors and Collaborators
Celgene
Investigators
Study Chair: Guenter Voraberger, MD Celgene Austria

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02555813     History of Changes
Other Study ID Numbers: ABI-007-PANC-006
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Celgene:
Metastatic Pancreatic Cancer
nab-Paclitaxel
Gemcitabine
Non-interventional

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs