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Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459757
First Posted: October 26, 2011
Last Update Posted: June 19, 2013
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

Condition Intervention
GIST Other: non-interventional

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib [ Time Frame: 9 months ]

Enrollment: 322
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Data generated from the past sunitinib A6181036 GIST study Other: non-interventional
Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.

Detailed Description:
This is a non-interventional trial. No active patients will participate in this study. Only data generated from the A6181036 study will be utilized for correlational purposes. The A6181036 study data in addition to mutational status data previously analyzed but not collected as part of the A6181036 study in the same patient population
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinical outcomes data generated from the sunitinib A6181036 study in GIST correlated with mutational status data previously analyzed for the same patients but not collected as part of the A6181036 study.
Criteria

Inclusion Criteria:

  • GIST subjects that participated in the A6181036 study that had mutational status data analyzed.

Exclusion Criteria:

  • Subjects not participating in the A6181036 study
  Contacts and Locations
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): NCT01459757


  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01459757     History of Changes
Other Study ID Numbers: A6181199
First Submitted: October 24, 2011
First Posted: October 26, 2011
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Pfizer:
Retrospective
GIST
sunitinib
mutational

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors