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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01260194
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/=18 years of age
* Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* HER2 positive tumor (primary tumor or metastasis
* ECOG Performance status 0, 1 or 2
* Life expectancy of at least 3 months
Exclusion Criteria:
* Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
* Patients with active (significant or uncontrolled) gastrointestinal bleeding
* Residual relevant toxicity resulting from previous chemotherapy
* Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01260194
Study Brief:
Protocol Section:
NCT01260194