NCT02951091Completed
Biomarker-Integrated Umbrella, Advanced Gastric Cancer
The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 30 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 400 (actual)
- First submitted
- 28 Oct 2016
- Start date
- 1 Jan 2016
- Primary completion date
- Dec 2021
- Lead sponsor
- Yonsei University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02951091
What you commit to
- Study type: Interventional
- Participants enrolled: 400
- From 1 Jan 2016 to the primary completion date, Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.