Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
- Registration Number
- NCT01524848
- Lead Sponsor
- Scandinavian Sarcoma Group
- 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) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label Pazopanib Single arm pazopanib
- Primary Outcome Measures
Name Time Method Disease control rate Week 12 The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) The patients will be followed for the duration of the trial treatment, an expected average of 6 months Progression free survival (KM analysis) for all patients administered the study drug
DCR in relation to mutation Week 12 Disease control rate as described above in relation to the type of mutation of the primary tumor if this is available (not mandatory)
DCR in relation to plasma concentration Week 12 Disease control rate as defined above in relation to the trough level (plasma concentration) of the study drug at week 12
Toxicity The patients will be followed for the duration of the trial treatment + 1 month, an expected average of 7 months Recording of adverse events including SAE/SAR for all patients administered the study drug
Overall response rate The patients will be followed for the duration of the trial treatment, an expected average of 6 months ORR = CR+PR at the time of best response during the study period
Trial Locations
- Locations (16)
Aarhus University Hospital, dept. of Oncology
🇩🇰Aarhus, Denmark
Herlev Hospital, dept. of Oncology
🇩🇰Herlev, Denmark
Helsinki University Hospital, dept. of oncology
🇫🇮Helsingfors, Finland
Kuopio University Hospital Cancer Center
🇫🇮Kuopio, Finland
Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg
🇩🇪Berlin, Germany
Universitätsklinikum Essen, Innere klinik und Poliklinik
🇩🇪Essen, Germany
Studienzentrale chirurgische klinik, Universitäts medizin Mannheim
🇩🇪Mannheim, Germany
Dept of Oncology, Haukeland University Hospital
🇳🇴Bergen, Norway
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Dept of Oncology, St Olav Hospital
🇳🇴Trondheim, Norway
Scroll for more (6 remaining)Aarhus University Hospital, dept. of Oncology🇩🇰Aarhus, Denmark