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Status:

COMPLETED

Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

Lead Sponsor:

Scandinavian Sarcoma Group

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Gastrointestinal Stromal Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs...

Eligibility Criteria

Inclusion

  • Eligibility Criteria:
  • Metastatic and/or locally advanced GIST, with diagnosis based on histology with positive c-kit and/or DOG-1, or with a GIST-typical mutation in KIT or PDGFR
  • Measurable disease on CT (computed tomography) as defined by RECIST criteria; at least one measurable lesion not given radiotherapy
  • History of progressive disease on CT according to RECIST criteria after both imatinib and sunitinib treatment, and also after nilotinib if this drug has been given
  • No other TKIs given than imatinib, sunitinib and nilotinib
  • Age at least 18 years at the time of diagnosis of GIST
  • WHO performance status 0-2
  • Resolution of all toxic side effects from earlier TKI treatment and any other potential non-TKI treatment to grade 1 or below
  • Sufficient organ functions as defined in the protocol
  • Absence of earlier or present certain other conditions as defined in the protocol
  • No pregnancy or lactation
  • Women with childbearing potential must accept the use of adequate contraception throughout the study period
  • Written informed consent

Exclusion

    Key Trial Info

    Start Date :

    February 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2016

    Estimated Enrollment :

    72 Patients enrolled

    Trial Details

    Trial ID

    NCT01524848

    Start Date

    February 1 2012

    End Date

    November 1 2016

    Last Update

    May 10 2017

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    Aarhus University Hospital, dept. of Oncology

    Aarhus, Denmark, DK-8000 Aarhus C

    2

    Herlev Hospital, dept. of Oncology

    Herlev, Denmark, 2730

    3

    Helsinki University Hospital, dept. of oncology

    Helsingfors, Finland, FI-00029

    4

    Kuopio University Hospital Cancer Center

    Kuopio, Finland, FI-70029