NCT03061708

Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy

Phase II Trial of Single Agent AZD2014 in RICTOR Amplified or Over-expressed GC Patients as Second-line Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 3 treatment discontinuation are met). Patients may continue 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. The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest, abdomen and pelvis. RECIST 1.1 scans will be analysed by the investigator on site.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	AZD2014	mTOR inhibitor

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-11-16
• Completion: 2018-11-16
• First posted: 2017-02-23
• Last updated: 2019-05-20

Locations

1 site across 1 country: South Korea