NCT02451956

Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, single center phase II study of AZD5363 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or amplification as a second line chemotherapy. Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed of 25 patients. 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 enrollment, 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.

Detailed description

AZD5363 is a highly potent adenosine triphosphate (ATP)-competitive AKT inhibitor with IC50\<10nmol/l for all three AKT isoforms. AZD5363 is well designed to inhibit the important main signal pathway in various human cancer. AZD5363 is a specific inhibitor of the AKT pathway which is activated in a wide spectrum of tumours.The combination of AZD5363 to standard chemotherapy, paclitaxel, might improve the outcomes of 2nd line therapy in advanced gastric cancer patients .

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	AZD5363	Dosage and Schedule : AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week
DRUG	paclitaxel	paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle.

Timeline

• Start date: 2015-01-07
• Primary completion: 2019-05-24
• Completion: 2019-05-24
• First posted: 2015-05-22
• Last updated: 2019-12-30

Locations

1 site across 1 country: South Korea