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OpenTrials
Completed

NCT Number: NCT02951091

Biomarker-Integrated Umbrella, Advanced Gastric Cancer

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • Male or female; ≥ 19 years of age
  • On or progression after 1st line palliative chemotherapy
  • Subjects with evaluable lesion (using RECIST 1.1 criteria)
  • 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

Treatment and study plan

biomarker screening

Other

immunohistochemistry and in situ hybridization

Primary outcomes

  1. progression free survival

    Time frame: 6 weeks

    progression free survival

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2024
First posted
Nov 1, 2016
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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