NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Stomach Neoplasms
Date of first enrollment	23/02/2015
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Ramucirumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 8 mg/kg ramucirumab given intravenously (IV) on days 1 and 8 in combination with capecitabine and cisplatin in Part A, on days 1 and 8, every 3 weeks, in combination with S-1 and cisplatin in Part B, and on days 1 and 8 in combination with S-1 and oxaliplatin in Part C. Generic name etc : Capecitabine INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14 in Part A. Generic name etc : Cisplatin INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles) in Part A and 60 mg/m^2 on day 8 of each 35 day cycle (up to 8 cycles) in Part B. Generic name etc : S-1 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 in Part B and on days 1 through 14 in Part C. Generic name etc : Oxaliplatin INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle (up to 8 cycles) in Part C.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-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.
Exclude 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 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.