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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02021500




Registration number
NCT02021500
Ethics application status
Date submitted
20/12/2013
Date registered
27/12/2013
Date last updated
1/11/2019

Titles & IDs
Public title
A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
Scientific title
MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046
Secondary ID [1] 0 0
ABI-007-PANC-CA046C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - ABI-007

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)


Treatment: Drugs: 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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
up to 3 years
Secondary outcome [1] 0 0
Disease progression
Timepoint [1] 0 0
up to 3 years

Eligibility
Key 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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Consent refused for any reason

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/04/2015
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
HOCA - the Wesley Clinic for Heamatology and Oncology - Auchenflower
Recruitment hospital [4] 0 0
Mater Medical Center - South Brisbane
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Austria
State/province [14] 0 0
St. Pölten
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Austria
State/province [16] 0 0
Wels
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Clichy
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Germany
State/province [24] 0 0
Munchen
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Italy
State/province [26] 0 0
San Giovanni Rotundo
Country [27] 0 0
Italy
State/province [27] 0 0
Verona
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Ukraine
State/province [30] 0 0
Dnipropetrovsk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Victoria Manax, MD
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02021500