Solid Tumor Clinical Trial
Official title:
SAMSUNG MEDICAL CENTER
Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy
Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014)
monotherapy. Study-arm is composed of 27 patients.
Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy Tumour
evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first
dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16
weeks until objective disease progression (within a window of +/- 7 days of the scheduled
date).
Study treatment will be continued until objective disease progression (unless other criteria
for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond
progression (according to RECIST 1.1), at the discretion of the investigator if they are
clinically benefiting from the treatment and they do not meet any other discontinuation
criteria.
If a patient discontinues study treatment prior to disease progression, they should continue
to be assessed using RECIST 1.1 until disease progression and then followed up for survival.
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