A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

Back to Search
Print
Bookmark Trial

NCT00457743

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kashiwa, Chiba, , Japan
See other locations
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
20-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).

- Patients previously treated with imatinib mesylate.

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


- Patients who have not recovered from the acute toxic effects of previous
antineoplastic therapy or treatment with imatinib mesylate.


- Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4
weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2
weeks prior to starting therapy.

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  ICMJE A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Official Title  ICMJE A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
Brief Summary

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE Drug: Sunitinib malate (SU011248)
SU011248
Study Arms  ICMJE Experimental: SU011248
25 , 50 or 75 mg/day of SU011248
Intervention: Drug: Sunitinib malate (SU011248)
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2007)		36
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
  • Patients previously treated with imatinib mesylate.

Exclusion Criteria:

  • Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
  • Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457743
Other Study ID Numbers  ICMJE A6181045
JapicCTI-070386
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP