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

NCT01459757

Last updated date
Study Location
City of Hope
Duarte, California, 91010, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
GIST
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects not participating in the A6181036 study

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GISTNon-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib NCT01459757
  1. Duarte, California
  2. Washington, District of Columbia
  3. Gainesville, Florida
  4. Gainesville, Florida
  5. Gainesville, Florida
  6. Tampa, Florida
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Minneapolis, Minnesota
  10. Portland, Oregon
  11. Seattle, Washington
  12. Seattle, Washington
  13. Randwick, New South Wales
  14. Kurralta Park, South Australia
  15. East Melbourne, Victoria
  16. Leuven,
  17. Montreal, Quebec
  18. Herlev,
  19. Helsinki,
  20. Bordeaux Cedex,
  21. Lyon Cedex,
  22. Marseille,
  23. Berlin,
  24. Duesseldorf,
  25. Koeln,
  26. Mumbai, Maharashtra
  27. Seoul,
  28. Seoul,
  29. Leiden,
  30. Warszawa,
  31. Bratislava,
  32. Barcelona,
  33. Sevilla,
  34. Lausanne,
  35. London,
  36. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib
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
Brief Summary Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.
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
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition GIST
Intervention 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.
Study Groups/Cohorts Data generated from the past sunitinib A6181036 GIST study
Intervention: Other: non-interventional
Publications * Reichardt P, Demetri GD, Gelderblom H, Rutkowski P, Im SA, Gupta S, Kang YK, Schöffski P, Schuette J, Soulières D, Blay JY, Goldstein D, Fly K, Huang X, Corsaro M, Lechuga MJ, Martini JF, Heinrich MC. Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial. BMC Cancer. 2016 Jan 15;16:22. doi: 10.1186/s12885-016-2051-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2013)
322
Original Estimated Enrollment
 (submitted: October 25, 2011)
500
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   India,   Korea, Republic of,   Netherlands,   Poland,   Slovakia,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Italy
 
Administrative Information
NCT Number NCT01459757
Other Study ID Numbers A6181199
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2013