In one (1%) of 104 patients in the ramucirumab group (cardiac arrest) and two (2%) Treatment-related deaths (deemed related by the investigator) occurred In the ramucirumab group, 56 (55%) in the merestinib group, and 48 (48%) in the pooled Serious adverse events occurred in 53 (51%) patients Placebo group), thrombocytopenia (36 19 and 17 ), and anaemia (28 Group 48 of 102 in the merestinib group and 33 of 100 in the pooled Worse adverse events were neutropenia (51 of 104 patients in the ramucirumab Vs placebo 0♹2, two-sided stratified p=0♶4). Median progression-free survival was 6♵ months (80%ĬI 5♷–7♱) in the ramucirumab group, 7♰ months (6♲–7♱) in the merestinib group,Īnd 6♶ months (5♶–6♸) in the pooled placebo group (ramucirumab vs placebo hazard ratio 1♱2, two-sided stratified p=0♴8 merestinib The median follow-up time for progression-free survival at data cutoff (Feb 16, 2018) (n=102), or pooled placebo (n=101) 306 received at least one dose of study treatment. Findingsīetween May 25, 2016, and Aug 8, 2017, 450 patients were assessed for eligibilityĪnd 309 (69%) were enrolled and randomly assigned to ramucirumab (n=106), merestinib
This trial is registered with, NCT02711553,Īnd long-term follow-up is ongoing. The safety analysis was done in all patients who received at least one dose of theirĪssigned treatment. Was investigator-assessed progression-free survival (in the intention-to-treat population). To treatment assignment within the intravenous and oral groups. Participants, investigators, and the study funder were masked Of six) and was stratified by primary tumour site, geographical region, and presence Was done by an interactive web response system using a permuted block method (blocks NPI record contains FOIA-disclosable NPPES health care provider information. The 1235361643 NPI number is assigned to the healthcare provider ARGEN-MEDICAL, PLLC, practice location address at 5225 ROUTE 347 STE 70 PORT JEFFERSON STATION, NY, 11776-2061. All participants received intravenous cisplatin 25 mg/m 2 and gemcitabine 1000 mg/m 2 (on days 1 and 8 in 21-day cycles), for a maximum of eight cycles. This webpage represents 1235361643 NPI record. Until disease progression, unacceptable toxicity, death, or patient or investigator (on days 1 and 8 in 21-day cycles) or oral merestinib 80 mg or placebo (once daily) Randomly assigned (2:1:2:1) to receive either intravenous ramucirumab 8 mg/kg or placebo Response Evaluation Criteria in Solid Tumors version 1.1. Recurrent, or metastatic biliary tract adenocarcinoma, who were treatment-naive, agedġ8 years or older, with an Eastern Cooperative Oncology Group performance status ofĠ or 1, estimated life expectancy of 3 months or more, and measurable disease per We enrolled patients with histologically or cytologically confirmed, non-resectable,
We did a randomised, double-blind, phase 2 study at 81 hospitals across 18 countries. The Lancet Regional Health – Western Pacific.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.All other trademarks are trademarks of their respective owners or holders. or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Argon, Argon Medical Devices, Atrieve, BioPince, Choice Lock, CLEANER, CLEANER XT, CLEANER 15, First PICC, FirstStic, FlexStrand, MaxiCell, Option, Osty-Core, Pro-Mag, SKATER, Slip-Coat, SuperCore Techna-Cut, TLAB, T-Lok, TruCore, TruTrack, UltraStream, V-Stick, V-Mark. products in your area.Īrgon Medical Devices, Inc.
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