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    Association details:
    Biomarker:KIT expression
    Cancer:Gastrointestinal Stromal Tumor
    Drug:imatinib (c-KIT inhibitor, Bcr-abl tyrosine kinase inhibitor, PDGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    Gleevec is a kinase inhibitor indicated for the treatment of...Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
    Test:
    Dako c-KIT pharmDx
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    JAMA Oncol
    Title:

    Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results: Analysis of Phase 3 SWOG Intergroup Trial S0033

    Published date:
    07/01/2013
    Excerpt:
    ...189 survived 8 years or longer, including 95 in the 400-mg/d dose arm and 94 in the 800-mg/d arm. The 10-year estimate of overall survival was 23% (95% CI, 20%-26%). Among 142 long-term survivors, imatinib was the sole therapy administered in 69 (48.6%), with additional systemic agents administered to 54 patients (38.0%).
    DOI:
    10.1001/jamaoncol.2016.6728
    Trial ID:
    SWOG-S0033
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

    Excerpt:
    ...Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay....
    Trial ID:
    NCT00367861
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery

    Excerpt:
    ...- Patient must have a histologic diagnosis of primary GIST (without peritoneal or distant metastasis) that expresses Kit protein by immunohistochemistry and have tumor size >= 3cm in maximum dimension...
    Trial ID:
    NCT00041197
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Jejunoileal vs Gastric GIST in the Era of Imatinib.

    Excerpt:
    ...Number of patients with a molecular analysis positive for KIT mutation`KIT Gene mutation`Number of patients with a molecular analysis positive for PDGFRA mutation`PDGFRA Gene mutation`Number of patients with immunohistochemical expression of CD117`Expression of CD117`Number of patients with immunohistochemical expression of DOG1`Expression of DOG1`Number of patients with recurrence after treatment with tyrosinkin inhibitors.`...
    Trial ID:
    NCT03923400
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

    Excerpt:
    ...- Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block...
    Trial ID:
    NCT00028002
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ph II Study of Perifosine Plus Gleevec for Patients With GIST

    Excerpt:
    ...- Histologically confirmed diagnosis of Kit expressing advanced GIST....
    Trial ID:
    NCT00455559
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

    Excerpt:
    ...The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by central pathology....
    Trial ID:
    NCT00867113
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor

    Excerpt:
    ...- Immunohistochemical confirmation of KIT (CD117) expression by tumor as documented by DAKO antibody staining...
    Trial ID:
    NCT00685828
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

    Excerpt:
    ...- Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;...
    Trial ID:
    GIST-TEN
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST

    Excerpt:
    ...Patients must have immunohistochemical documentation of kit expression in the tumor using the DAKO A4502 or other acceptable antibody....
    Trial ID:
    NCT00500188
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

    Excerpt:
    ...- Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block...
    Trial ID:
    NCT01267695
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

    Excerpt:
    ...Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry....
    Trial ID:
    NCT00940563
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

    Excerpt:
    ...- All patients must have immunohistochemical documentation of KIT (CD117) expression by tumor documented by DAKO antibody staining for suggested methodology) Material must be submitted to the CALGB Pathology Coordinating Center for pathology review; it is strongly recommended that snap-frozen tissue biopsy and sera be stored for future submission whenever possible...
    Trial ID:
    SWOG-S0033
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

    Excerpt:
    ...Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required...
    Trial ID:
    NCT00237185