This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
avapritinib tablet
Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy
Villejuif, Val-de-Marne, France
Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs for avapritinib are, regardless of grade or causality: * cognitive effects which include the following terms: memory impairment, cognitive disorder, confusional state and encephalopathy. * intracranial bleeding including haemorrhage intracranial, cerebral haemorrhage , and subdural haematoma.
Time frame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
Number of Participants With Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of all serious AEs, regardless of causality is located in Reported AE section.
Time frame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
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