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NCT02951091 Clinical Trial

Biomarker-Integrated Umbrella, Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:
The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02951091
Other study ID # 4-2015-0616
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 2016
Est. completion date December 2022

Study information
Verified date July 2022
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. Male or female; = 19 years of age 4. On or progression after 1st line palliative chemotherapy 5. Subjects with evaluable lesion (using RECIST 1.1 criteria) 6. Subjects who meet the following criteria: - Absolute neutrophil count = 1000 /µL - Platelet count = 75,000/ µL - Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance =60 mL/min - aspartate aminotransferase and alanine transaminase 3 x upper limit of normal Exclusion Criteria: - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• biomarker screening
immunohistochemistry and in situ hybridization

Locations
Country Name City State
Korea, Republic of Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression free survival 6 weeks
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