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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021500
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment
Pancreatic Cancer Drug: ABI-007

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

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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 : January 2, 2014
Actual Primary Completion Date : April 16, 2015
Actual Study Completion Date : April 16, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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)




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 3 years ]
    Number of participants who survive


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled in study CA046
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021500


Locations
Show Show 39 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Victoria Manax, MD Celgene
Publications:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02021500    
Other Study ID Numbers: ABI-007-PANC-CA046C
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents