Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Eli Lilly Japan K.K.0 个研究点开始时间: 2015年2月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•A histopathologically or cytologically confirmed diagnosis of gastric or 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.

•-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 VEGF (vascular endothelial growth factor) 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.

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