Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT01461057
Eligibility Criteria:
Inclusion Criteria:
* Adult participants, greater than or equal to (\>=) 18 of age
* Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1
* HER2-positive tumor
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months
Exclusion Criteria:
* Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Active (significant or uncontrolled) gastrointestinal bleeding
* Abnormal laboratory values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01461057
Study Brief:
Protocol Section:
NCT01461057