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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Detroit, Michigan, 48201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Stromal Tumor
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

- Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib
400 mg daily.

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

- Current treatment with any chemotherapy other than imatinib.

- Current treatment with any dose of imatinib other than 400 mg

NCT00372567
Pfizer
Terminated
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
  • Drug: sunitinib malate
    37.5 mg daily
    Other Name: Sutent
  • Drug: imatinib mesylate
    800mg daily
  • Experimental: A
    Intervention: Drug: sunitinib malate
  • Active Comparator: B
    Intervention: Drug: imatinib mesylate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
69
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion Criteria:

  • Current treatment with any chemotherapy other than imatinib.
  • Current treatment with any dose of imatinib other than 400 mg
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hong Kong,   Italy,   Korea, Republic of,   Spain,   United Kingdom,   United States
France
 
NCT00372567
A6181112
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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