Clinical trial NCT02359058 (phase 1, status: completed)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: ramucirumab, capecitabine, cisplatin, s-1, oxaliplatin
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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.