AzTrials
AzTrials

Pancreatic CancerNCT02021500

A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.

An observational study of Pancreatic Cancer, run by Celgene at 39 sites in 9 countries.

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

A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pancreatic Cancer
What is being tested?
ABI-007
How many people
40 participants
Where
39 sitesin 9 countries
Study dates
2 Jan 2014to 16 Apr 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients previously enrolled in study CA046

Who may be able to join

  • Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data)

Who cannot join

  • Consent refused for any reason

Trial locations and contacts

39 sites in 9 countries.

39 sites in 9 countries

United States16 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Florida Cancer Specialists

    Englewood, Florida, 34223

  • Fairfax-Northern Virginia Haematology-Oncology

    Fairfax, Virginia, 22033

  • Indiana University

    Indianapolis, Indiana, 46202-5149

  • Arena Oncology Associates

    Lake Success, New York, 11042

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Froedtert and Medical College ID Clinic

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • South Texas Oncology and Hematology (STOH)

    San Antonio, Texas, 78229

  • TGen Clinical Research Services

    Scottsdale, Arizona, 85004

  • Mayo Clinic

    Scottsdale, Arizona, 85259-5499

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Florida Cancer Specialist

    Tavares, Florida, 32778

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Australia4 sites

  • HOCA - the Wesley Clinic for Heamatology and Oncology

    Auchenflower, Queensland, 4066

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater Medical Center

    South Brisbane, 4101

Other trials in Australia

Canada4 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Centre Hospsitalier Universitaire de Montreal - Notre Dame

    Montreal, Quebec, H2L 4M1

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy4 sites

  • Ospedale San Raffaele S.r.l.

    Milan, 20133

  • Azienda Ospedaliera Niguarda Cà Granda

    Milan, 20162

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotundo, 71013

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37134

Other trials in Italy

Austria3 sites

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

France2 sites

  • Hôpital Beaujon

    Clichy, 92118

  • Hôpital Saint Antoine

    Paris, 75571

Other trials in France

Germany2 sites

  • Kliniken Essen-Mitte

    Essen, 45136

  • LMU Klinikum der Universität München

    München, 81377:

Other trials in Germany

Ukraine1 site

  • Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council

    Dnipropetrovsk, 49102

Other trials in Ukraine

About this study

Official title: MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046

A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

Read the detailed description

A study to collect survival status of CA046 subjects who were know to be alive at the last report of vital status for CA046 - approximate timeframe - end of March, 2013. Once consent is given, on a quarterly basis, information on status will be collected to include:

  • Vital Status
  • Date of disease progression
  • Subsequent anticancer therapy for pancreatic adenocarcinoma
Being tested
ABI-007
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • ABI-007Drug

    No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)

Study groups in NCT02021500
Study groupRoleWhat they receive
Patients previously enrolled in study CA046No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)
Receives: Drug: ABI-007

What is being measured

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

  1. Overall Survival

    Number of participants who survive

    Measured: up to 3 years

Secondary outcomes (1)

  1. Disease progression

    Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046

    Measured: up to 3 years

Timeline

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

  1. First posted27 Dec 2013 (estimated)
  2. Study start2 Jan 2014
  3. Primary completion16 Apr 2015
  4. Study completion16 Apr 2015

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
Other
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02021500
Sponsor's protocol ID
ABI-007-PANC-CA046C
Status last verified
Oct 2019
First submitted
20 Dec 2013
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.

    PubMed 26802153

  • Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

    PubMed 26802160

  • Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.

    PubMed 26655559

  • Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

    PubMed 26372701

  • Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

    PubMed 25638248

  • Vogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.

    PubMed 25398812

  • Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

    PubMed 24131140

  • Al-Hajeili M, Azmi AS, Choi M. Nab-paclitaxel: potential for the treatment of advanced pancreatic cancer. Onco Targets Ther. 2014 Feb 4;7:187-92. doi: 10.2147/OTT.S40705. eCollection 2014.

    PubMed 24523592

  • Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

    PubMed 25582141

  • Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28.

    PubMed 27351217

  • Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.

    PubMed 27085323

  • Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

    PubMed 27284481

  • Vogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.

    PubMed 27769210

  • Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.

    PubMed 28203092

  • Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.

    PubMed 27841795

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, run by Celgene at 39 sites in 9 countries.

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 1 inclusion and 1 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Australia, Canada, Italy, Austria and 4 more countries. 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?

Overall Survival (time frame: up to 3 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 NCT02021500, which also lists 15 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 1 Nov 2019.

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