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Biomarker-Integrated Umbrella, Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02951091
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Young Rha, Yonsei University

Brief 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.

Condition or disease Intervention/treatment
Gastric Cancer Other: biomarker screening

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
biomarker group
400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets [Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.
Other: biomarker screening
immunohistochemistry and in situ hybridization
control group



Primary Outcome Measures :
  1. progression free survival [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951091


Contacts
Contact: Hyo Song Kim, Ph.D hyosong77@yuhs.ac

Locations
Korea, Republic of
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyosong Kim, M.D    82-2-2228-8124    hyosong77@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Sun Young Rha, Ph.D Severance Hospital

Responsible Party: Sun Young Rha, professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02951091     History of Changes
Other Study ID Numbers: 4-2015-0616
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases