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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02359058
Eligibility Criteria:
Inclusion Criteria:
* A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
* Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after \>6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
* Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
* The participant has adequate organ function.
* Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version \[v\]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer.
* Female participants of childbearing potential must have a negative serum or urinary pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.
Exclusion Criteria:
* A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
* Uncontrolled arterial hypertension, despite standard medical management.
* A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
* Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
* Radiation therapy within 14 days prior to enrollment.
* Received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
* Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
* A serious illness or medical condition(s).
* Pregnant or breastfeeding.
* Dysphagia for oral medication.
* Known allergy or hypersensitivity to any study treatment.
* Human epidermal growth factor receptor (HER) 2 status of positive.
* Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02359058
Study Brief:
Protocol Section:
NCT02359058