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

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

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

  1. Re-verified, no change to tracked fieldsv71
  2. Minor Study completion date: Mar 19, 2026 to Mar 31, 2027v70
  3. 2 versions Re-verified since Apr 8, 2025, no change to tracked fieldsv68-v69
  4. Minor Study completion date: Mar 8, 2025 to Mar 19, 2026v67
  5. 3 versions Re-verified since Jul 2, 2024, no change to tracked fieldsv64-v66
Show 42 earlier versionsHide 42 earlier versions
  1. Minor Study completion date: Mar 8, 2025v63
  2. 20 versions Re-verified since Oct 1, 2018, no change to tracked fieldsv43-v62
  3. Minor Primary completion date: Feb 2010 to Feb 11, 2010
    • Start date: Sep 2005 to Sep 14, 2005
    • Study sites revised (6)
    v42
  4. 2 versions Re-verified since May 26, 2016, no change to tracked fieldsv40-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
    v39
  6. Minor Enrollment target: 42 to 38
    • Eligibility criteria expanded, about 18 words
    • Study description expanded, about 1 word
    v38
  7. Notable Results first posted: Jan 21, 2014
    • Primary endpoint revised
    • Study sites: 1 to 3
    • Secondary endpoints: 4 to 2
    v37
  8. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jan 2100 to Feb 2010
    • Site details revised
    v36
  9. 3 versions Re-verified since Aug 14, 2012, no change to tracked fieldsv33-v35
  10. Notable Lead sponsor: University of Chicago to National Cancer Institute (NCI)
    • Primary completion date: Jul 2006 to Jan 2100
    • Study site revised
    • Study arms: 0 to 1
    v32
  11. 4 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv28-v31
  12. Minor Study sites: 2 to 1v27
  13. Minor Interventions: antiangiogenesis therapy (Procedure), enzyme inhibitor therapy (Procedure), sorafenib tosylate (Drug) to sorafenib tosylate (Drug)v26
  14. Study Status, Referencesv25
  15. Minor Primary completion date: Jul 2006v24
  16. Minor Study sites revised (2)v23
  17. Minor Study sites revised (2)v22
  • 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
(from sponsor)
Gastrointestinal Stromal Tumor
Related terms Gastrointestinal Stromal Tumors
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov