RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expressio

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0000347
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Pathologically proven non-resectable adenocarcinoma of stomach with measurable disease
-Prior failure (progression during or within 6 months after) of 1st line palliative chemotherapy including fluoropyrimidine (capecitabine, S-1, or 5-FU) and platinum (cisplatin or oxaliplatin) for metastatic or recurrent gastric cancer
-High expression of pS6 Ser 240/4 (proportion of pS6 Ser 240/4 positive cancer cells by immunohistochemistry > 10%)
-Age 20 to 75 years old
-Estimated life expectancy of more than 3 months
-ECOG performance status of 2 or lower
-Adequate bone marrow function
-Adequate kidney function
-Adequate liver function
-Written informed consent

Exclusion Criteria

- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Obvious bowel obstruction or active gastrointestinal bleeding
- Other serious illness or medical conditions

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4-month progression-free survival

Secondary Outcome Measures

Name	Time	Method
response rate;toxicity;overall survival;biomarker assessment