Analysis of predictive biomarker and analysis of correlations between toxicities and SNPs that can be related to pharmacokinetics, in ramucirumab plus paclitaxel therapy for elderly patients with unresectable or recurrent gastric cancer

Not Applicable

• Conditions: unresectable or recurrent gastric cancer

• Registration Number: JPRN-UMIN000021743
• Lead Sponsor: Tohoku Clinical Oncology Research and Education Society (T-CORE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who fulfill the following criteria for exclusion are excluded. 1) Received taxane-based regimen. 2) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 3) Active infection and inflammation. 4) Active hepatitis. 5) Current or past history within 1 year of serious heart disease that requires hospitalization 6) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 7) Active gastrointestinal bleeding. 8) Gastrointestinal perforation or histula, artelial embolism within 6 months or venous thromboembolism within 3 months before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Grade 2 or more neuropathy. 11) Effusion that requires drainage. 12) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Tissue biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from ramucirumab plus paclitaxel therapy 2.Serum biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from ramucirumab plus paclitaxel therapy 3.SNPs that correlate with toxicities from ramucirumab plus paclitaxel therapy