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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02076594
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent prior to beginning protocol specific procedures
* Male or female \> 18 years of age
* Histologically proven diagnosis of adenocarcinoma of the stomach
* HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy
* Locally advanced (non resectable) or metastatic gastric cancer
* Presence of measurable disease with at least one measurable lesion by means of CT scan or MRI in not previously irradiated area(s) (according to RECIST criteria (version 1.1)
* Life expectancy of \>/= 3 months
* ECOG performance status of 0-2 at study entry
* Neutrophils \>/= 2.0 x 1000000000/L, platelets \>/= 100 x 1000000000/L, and hemoglobin \>/= 10 g/dL
* Bilirubin level either normal or \</= 1.5 x ULN
* AST and ALT \</= 2.5 X UNL (\</= 5 x ULN if liver metastasis are present
* Alkaline phosphatase (ALP) \</= 2.5 X ULN; patients with alkaline phosphatase \> 2.5x ULN and AST and ALT \</= 1.5 x ULN are equally eligible
* Serum creatinine \< 1.5 x ULN. In presence border-line values, the calculated creatinine clearance should be \>/= 60 mL/min
* Negative pregnancy test (if female in reproductive years)
* Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential
* Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol
Exclusion Criteria:
* Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry
* Concurrent chronic systemic immune therapy
* Any investigational agent(s) 4 weeks prior to entry
* Clinically relevant coronary artery disease or a history of a myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months
* Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment
* Known drug abuse/ alcohol abuse
* Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment
* History of clinically relevant psychiatric disability precluding informed consent
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Pregnant or breastfeeding women
* Active uncontrolled infection(s)
* Positive for HIV serology and/or viral hepatitis B or C
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02076594
Study Brief:
Protocol Section:
NCT02076594