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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
vistusertib(AZD2014) is selective inhibitor of mTOR kinases and inhibits signalling of both mTOR complexes, mTORC1 and mTORC2.
Samsung Medical Center
Seoul, South Korea
Objective reponse rate (ORR) by RECIST 1.1
To investigate the efficacy and safety of vistusertib(AZD2014) single agent as salvage therapy in patients with TSC1or 2 null or TSC 1/2
Time frame: 12months
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