Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03061708
Status:
TERMINATED
Last Update Posted:
2019-05-20
First Post:
2017-02-10
Brief Title:
Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Trial of Single Agent AZD2014 in RICTOR Amplified or Over-expressed GC Patients as Second-line Therapy
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZD2014
Brief Summary:
Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle
Detailed Description:
Tumour evaluation using RECIST 11 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 3 treatment discontinuation are met Patients may continue AZD2014 beyond progression according to RECIST 11 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 11 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 The imaging modalities used for RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis RECIST 11 scans will be analysed by the investigator on site
Study treatment will be continued until objective disease progression unless other criteria for 3 treatment discontinuation are met Patients may continue AZD2014 beyond progression according to RECIST 11 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 11 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 The imaging modalities used for RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis RECIST 11 scans will be analysed by the investigator on site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None