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

Study Description

Brief 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 .

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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