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Metastatic Pancreatic CancerNCT02555813

Treatment of Pancreatic Cancer With Abraxane

An observational study of Metastatic Pancreatic Cancer, run by Celgene at 19 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Abraxane and Gemcitabine
Type of treatment
Injection or infusion
How many people
317 participants
Where
19 sitesAustria
Study dates
8 May 2015to 7 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Metastatic pancreatic cancer

Who may be able to join

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

Who cannot join

  • 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
  • -

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Austria19 sites

  • BHB Eisenstadt

    Eisenstadt, 7001

  • LKH Feldkirch

    Feldkirch, 6800:

  • Medical University Graz

    Graz, 8010

  • Medical University Innsbruck

    Innsbruck, 6020:

  • KH Elisabethinen Klagenfurt

    Klagenfurt, 9020

  • LKH Klagenfurt

    Klagenfurt, 9020

  • KH Krems

    Krems, 3500

  • LKH Leoben

    Leoben, 8700:

  • KH Barmherzige Schwestern Linz

    Linz, 4020:

  • LKH Salzburg

    Salzburg, 5020:

  • LKH St. Pölten

    Sankt Pölten, 3100:

  • LKH Steyr

    Steyr, 4400:

  • Medical University Vienna

    Vienna, 1090:

  • KH St. Josephs

    Vienna, 1130

  • KH Hanusch

    Vienna, 1140

  • LKH Vöcklabruck

    Vöcklabruck, 4840:

  • Klinikum Wels

    Wels, 4600:

  • LKH Wr. Neustadt

    Wiener Neustadt, 2700:

  • KH Zams

    Zams, 6511

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
Abraxane, Gemcitabine
Keywords
Metastatic Pancreatic Cancer, nab-Paclitaxel, Gemcitabine, Non-interventional
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbraxaneDrug

    Also called Nab-paclitaxel, ABI-007

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

  • GemcitabineDrug

    Also called Gemzar

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

Study groups in NCT02555813
Study groupRoleWhat they receive
Abraxane + GemcitabineAbraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression
Receives: Drug: Abraxane; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 years

Secondary outcomes (1)

  1. Best Overall Response

    Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR).

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study start8 May 2015
  3. Primary completion7 Sep 2020
  4. Study completion7 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555813
Sponsor's protocol ID
ABI-007-PANC-006
Status last verified
Oct 2020
First submitted
18 Sep 2015
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28795609

  • 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.

    PubMed 30209750

  • Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x.

    PubMed 29946913

  • Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

    PubMed 29932294

  • Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

    PubMed 30497432

  • Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.

    PubMed 30006989

  • Barnes JA, Ellis ML, Hwang S, Emarine J, Merwin P, Salinas GD, Musher BL. Identification of Educational Gaps Among Oncologists Who Manage Patients with Pancreatic Cancer. J Gastrointest Cancer. 2019 Mar;50(1):84-90. doi: 10.1007/s12029-017-0033-8.

    PubMed 29177608

  • Woo W, Carey ET, Choi M. Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther. 2019 Feb 21;12:1455-1463. doi: 10.2147/OTT.S167590. eCollection 2019.

    PubMed 30863113

  • Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

    PubMed 30768369

  • Prager GW, Oehler L, Gerger A, Mlineritsch B, Andel J, Petzer A, Wilthoner K, Sliwa T, Pichler P, Winder T, Heibl S, Gruenberger B, Laengle F, Hubmann E, Korger M, Pecherstorfer M, Djanani A, Neumann HJ, Philipp-Abbrederis K, Woll E, Trondl R, Arnold-Schrauf C, Eisterer W. Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study. Eur J Cancer. 2021 Jan;143:101-112. doi: 10.1016/j.ejca.2020.11.003. Epub 2020 Dec 6.

    PubMed 33296830

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Pancreatic Cancer, run by Celgene at 19 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555813, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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