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

Advanced Gastric Cancer Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 . ;

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT02451956
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: January 7, 2015
• Completion date: May 24, 2019