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Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 71 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v71

  2. Minor

    Completion date: Mar 19, 2026 to Mar 31, 2027

    Study Statusv70

  3. Minor

    2 amendments

    2 re-verifications since 2025-04-08, no change to tracked fields

    v68-v69

  4. Minor

    Completion date: Mar 8, 2025 to Mar 19, 2026

    Study Statusv67

  5. Minor

    3 amendments

    3 re-verifications since 2024-07-02, no change to tracked fields

    v64-v66

Show 42 earlier versions

  1. Minor

    Completion date: Mar 8, 2025

    Study Statusv63

  2. Minor

    20 amendments

    20 re-verifications since 2018-10-01, no change to tracked fields

    v43-v62

  3. Minor

    Primary completion date: Feb 2010 to Feb 11, 2010

    Start date: Sep 2005 to Sep 14, 2005; Study sites revised (6)

    Show what changed: Study sites
    Memorial Sloan- Kettering Cancer Center

    Study Status, Contacts/Locations, Baseline Characteristicsv42

  4. Minor

    2 amendments

    2 re-verifications since 2016-05-26, no change to tracked fields

    v40-v41

  5. Minor

    Study sites: 3 to 6

    Interventions: sorafenib tosylate (Drug) to Sorafenib Tosylate (Drug); Eligibility criteria shortened, about 18 words; Study description shortened, about 1 word

    Show what changed: Eligibility criteria
    [...] adiated area No known brain metastases Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 More than 3 months Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Bilirubin <= upper limit of normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal Creatinine ≤ 1.5 mg/dL Cr [...] sunitinib malate No prior sorafenib No prior inhibitors of mitogen-activated protein kinase (MAPK)-signaling intermediates No other investigational agent afte [...] ing criteria are met: On a therapeutic stable warfarin dose International Normalized [...] [...]
    Show what changed: Study description
    [...] malate-refractory disease). Patients receive oral sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in t [...]

    Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locationsv39

  6. Minor

    Enrollment target: 42 to 38

    Eligibility criteria expanded, about 18 words; Study description expanded, about 1 word

    Show what changed: Eligibility criteria
    [...] adiated area No known brain metastases Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 More than 3 months Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Bilirubin <= upper limit of normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal Creatinine ≤ 1.5 mg/dL Cr [...] sunitinib malate No prior sorafenib No prior inhibitors of mitogen-activated protein kinase (MAPK)-signaling intermediates No other investigational agent afte [...] ing criteria are met: On a therapeutic stable warfarin dose International Normalized [...] [...]
    Show what changed: Study description
    [...] malate-refractory disease). Patients receive oral sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in t [...]

    Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv38

  7. Notable

    Results first posted: Jan 21, 2014

    Primary endpoint revised; Study sites: 1 to 3; Secondary endpoints: 4 to 2

    Show what changed: Primary endpoints
    Objective responseResponse rate (partial response [PR] or complete response [CR])Rate
    Show what changed: Secondary endpoints
    Toxicity Progression-free survival (time to disease progression or death) as assessed using standard Kaplan-Meier methodsSurvival Overall survival as assessed using standard Kaplan-Meier methods Mutational status of KIT and PDGFASurvival

    Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures, Contacts/Locations, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv37

  8. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Primary completion date changed from estimate of Jan 2100 to Feb 2010; Site details revised

    Study Status, Contacts/Locationsv36

  9. Minor

    3 amendments

    3 re-verifications since 2012-08-14, no change to tracked fields

    v33-v35

  10. Notable

    Lead sponsor: University of Chicago to National Cancer Institute (NCI)

    Primary completion date: Jul 2006 to Jan 2100; Primary endpoint revised; Eligibility criteria shortened, about 17 words; and 5 more

    Show all 9 changes in this update
    • Notable Lead sponsor: University of Chicago to National Cancer Institute (NCI)
    • Notable Primary completion date: Jul 2006 to Jan 2100
    • Notable Primary endpoint revised
      Show what changed
      Objective response rate (partial andresponse [PR] or complete response [CR])
    • Minor Eligibility criteria shortened, about 17 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Histologically confirmed gastrointestinal stromal tumor No [...] ide of previously irradiated area No known brain metastases PATIENT CHARACTERISTICS: Performance status - ECOG 0-2 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Bilirubin normal AST and ALT < 2.5 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance > 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertensi [...] [...]
    • Minor Secondary endpoints: 2 to 4
      Show what changed
      Overall survivalToxicity Progression-free survival (time to disease progression or death) as assessed using standard Kaplan-Meier methods Overall survival as assessed using standard Kaplan-Meier methods Mutational status of KIT and PDGFA
    • Minor Study description expanded, about 42 words
      Show what changed
      PRIMARY OBJECTIVES: Primary DetermineI. To determine the objective response rate (partial and complete response) inof patients with imatinib mesylate- and sunitinib malate-resistant malignant gastrointestinal stromal tumor who are treated with sorafenibBAY 43-9006. SecondarySECONDARY OBJECTIVES: DetermineI. To determine the toxicity ofexperienced this drug in theseby patients with imatinib and sunitinib -resistant malignant gastrointestinal stromal tumor who are treated with BAY 43-9006. DetermineII. To thedetermine progression-free survival and overall survival ofin patients with imatinib and [...] [...]
    • Minor Study site revised
      Show what changed
      University of Chicago Comprehensive Cancer Research Center
    • Minor Collaborators shortened, about 4 words
      Show what changed
      National Cancer Institute (NCI)
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Referencesv32

  11. Minor

    4 amendments

    4 re-verifications since 2008-07-23, no change to tracked fields

    v28-v31

  12. Minor

    Study sites: 2 to 1

    Study Status, Contacts/Locationsv27

  13. Minor

    Interventions: antiangiogenesis therapy (Procedure), enzyme inhibitor therapy (Procedure), sorafenib tosylate (Drug) to sorafenib tosylate (Drug)

    Study Status, Arms and Interventionsv26

  14. Minor

    Study Status, References

    v25

  15. Minor

    Primary completion date: Jul 2006

    Study Statusv24

  16. Minor

    Study sites revised (2)

    Show what changed: Study sites
    OSUArthur ComprehensiveG. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Study Status, Contacts/Locationsv23

  17. Minor

    Study sites revised (2)

    Show what changed: Study sites
    OSU Comprehensive Cancer Center at James Cancer Hospital and Solove Research Institute

    Study Status, Contacts/Locationsv22

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Trial Details
NCT Number NCT00265798
Lead Sponsor National Cancer Institute (NCI)
Conditions Gastrointestinal Stromal Tumor
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov