Phase II Trial of Vistusertib（AZD2014） Single Agent in TSC1or 2 Null or TSC 1/2 Mutation Solid Cancer Patients Refractory to Standard Chemotherapy (TSC1/2_SC)
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|ClinicalTrials.gov Identifier: NCT03166176|
Recruitment Status : Withdrawn (lack of efficacy)
First Posted : May 25, 2017
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Vistusertib(AZD2014)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle|
|Masking:||None (Open Label)|
|Official Title:||SAMSUNG MEDICAL CENTER|
|Estimated Study Start Date :||March 2018|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
- Drug: Vistusertib(AZD2014)
vistusertib(AZD2014) is selective inhibitor of mTOR kinases and inhibits signalling of both mTOR complexes, mTORC1 and mTORC2.Other Name: AZD2014
- Objective reponse rate (ORR) by RECIST 1.1 [ Time Frame: 12months ]To investigate the efficacy and safety of vistusertib(AZD2014) single agent as salvage therapy in patients with TSC1or 2 null or TSC 1/2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166176
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|