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

October 30, 2019 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • South Brisbane, Australia, 4101
        • Mater Medical Center
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • HOCA - the Wesley Clinic for Heamatology and Oncology
  • Austria
      • St. Pölten, Austria, 3100
        • Landesklinikum St. Pölten
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Ontario
      • Barrie, Ontario, Canada, L4M6M2
        • Royal Victoria Regional Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospsitalier Universitaire de Montreal - Notre Dame
  • France
      • Clichy, France, 92118
        • Hopital Beaujon
      • Paris, France, 75571
        • Hopital Saint Antoine
  • Germany
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Munchen, Germany, 81377:
        • LMU Klinikum der Universitat Munchen
  • Italy
      • Milano, Italy, 20162
        • Azienda Ospedaliera Niguarda Cà Granda
      • Milano, Italy, 20133
        • Ospedale San Raffaele S.r.l.
      • San Giovanni Rotundo, Italy, 71013
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic
      • Scottsdale, Arizona, United States, 85004
        • Tgen Clinical Research Services
    • California
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Englewood, Florida, United States, 34223
        • Florida Cancer Specialists
      • Tavares, Florida, United States, 32778
        • Florida Cancer Specialist
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5149
        • Indiana University
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Arena Oncology Associates
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Pavillion
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology and Hematology (STOH)
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Fairfax-Northern Virginia Haematology-Oncology
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and Medical College ID Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously enrolled in study CA046

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Consent refused for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients previously enrolled in study CA046
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)
Drug: ABI-007
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 3 years
Number of participants who survive
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression
Time Frame: up to 3 years
Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Victoria Manax, MD, Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2014

Primary Completion (ACTUAL)

April 16, 2015

Study Completion (ACTUAL)

April 16, 2015

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (ESTIMATE)

December 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-007-PANC-CA046C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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