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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02021500
Collaborator
(none)
40
Enrollment
39
Locations
15.4
Actual Duration (Months)
1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046
Actual Study Start Date :
Jan 2, 2014
Actual Primary Completion Date :
Apr 16, 2015
Actual Study Completion Date :
Apr 16, 2015

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [up to 3 years]

    Number of participants who survive

Secondary Outcome Measures

  1. Disease progression [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Celgene

Investigators

  • Study Director: Victoria Manax, MD, Celgene

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02021500
Other Study ID Numbers:
  • ABI-007-PANC-CA046C
First Posted:
Dec 27, 2013
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Additional relevant MeSH terms:
Pancreatic Neoplasms
Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Nov 1, 2019