Solid Tumor Clinical Trial
Official title:
AZD2014 in RICTOR Amplified Solid Cancer
Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014).
Study-arm is composed of 27 patients.
Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle 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).
Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014).
Study-arm is composed of 27 patients.
Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle 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.
Assessments for survival should be made every 8 weeks following objective disease
progression. The details of first and subsequent therapies for cancer, after discontinuation
of treatment, will be collected.
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