Trial record 2 of 34 for:    celgene abi-007 | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02021500
First received: December 20, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Pancreatic Cancer
Drug: ABI-007

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Number of participants who survive


Secondary Outcome Measures:
  • Disease progression [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046


Estimated Enrollment: 70
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021500

Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 36 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Victoria Manax, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02021500     History of Changes
Other Study ID Numbers: ABI-007-PANC-CA046C
Study First Received: December 20, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
France: Direction de l'Evaluation des Médicaments et des produits Biologiques
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014