Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

Back to Search
Print
Bookmark Trial

NCT00716820

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

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


Patients not administered SUNITINIB MALATE(Sutent).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Gastrointestinal Stromal TumorsA Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
NCT00457743
  1. Kashiwa, Chiba
  2. Sapporo, Hokkaido
  3. Suita, Osaka
  4. Chuo-ku, Tokyo
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Gastrointestinal Stromal TumorsStudy Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
NCT00137449
  1. Boston, Massachusetts
  2. Lyon Cedex 08,
  3. Villejuif,
  4. Milano,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Gastrointestinal Stromal TumorsPost Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
NCT00444795
  1. Jung-gu, Daegu
  2. Nam-gu, Daegu
  3. Gangneung-si, Gangwon-do
  4. Bucheon, Gyeonggi-do
  5. Suwon, Gyeonggi-do
  6. Cheonnam, South Jeolla Province
  7. Anyang,
  8. Busan,
  9. Busan,
  10. Busan,
  11. Busan,
  12. Busan,
  13. Busan,
  14. Cheonnam,
  15. Daegu,
  16. Daegu,
  17. Daegu,
  18. Daejeon,
  19. Daejeon,
  20. Goyang,
  21. Gwang Joo,
  22. Gyeongsangnam-do,
  23. Iksan -Si,
  24. Incheon,
  25. Incheon,
  26. Jeonju,
  27. Nam-gu,
  28. Seongnam-si,
  29. Seoul,
  30. Seoul,
  31. Seoul,
  32. Seoul,
  33. Seoul,
  34. Seoul,
  35. Seoul,
  36. Seoul,
  37. Seoul,
  38. Seoul,
  39. Seoul,
  40. Seoul,
  41. Seoul,
  42. Seoul,
  43. Seoul,
  44. Seoul,
  45. Seoul,
  46. Ulsan,
  47. Wonju-si,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Gastrointestinal Stromal TumorsA Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
NCT01396148
  1. Los Angeles, California
  2. Boston, Massachusetts
  3. Boston, Massachusetts
  4. Brno,
  5. Brno,
  6. Brno,
  7. Marseille cedex 5,
  8. Marseille cedex 5,
  9. Marseille cedex 5,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Official Title Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.
Brief Summary The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).
Condition Gastrointestinal Stromal Tumors
Intervention Drug: SUNITINIB MALATE

SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.

The dosage may be decreased according to the patient's clinical condition."

Other Name: SUTENT
Study Groups/Cohorts SUNITINIB MALATE
Patients taking Sutent.
Intervention: Drug: SUNITINIB MALATE
Publications * Not Provided

*   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: November 7, 2017)		472
Original Estimated Enrollment
 (submitted: July 15, 2008)		600
Actual Study Completion Date September 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered SUNITINIB MALATE(Sutent).

Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00716820
Other Study ID Numbers A6181175
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 November 2017