105
Participants
Start Date
May 29, 2018
Primary Completion Date
December 12, 2018
Study Completion Date
February 8, 2021
Plinabulin
Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Pegfilgrastim
PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
Saline Placebo
Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
D5W Placebo
Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
"Municipal Institution Sumy Regional Clinical Oncology Dispensary", Sumy
Norton Cancer Institute, Louisville
Dnipropetrovsk City Multifunctional Hospital, Dnipro
Hematology/Oncology of the North Shore, Skokie
"Communal Institution of Kherson Regional Council Kherson regional oncological dispensary", Kherson
Prykarpatskiy Regional Oncological Center, Ivano-Frankivsk
Lviv State Oncological Regional Treatment and Preventive Center, Lviv
Heilongjiang Cancer Hospital, Harbin
Jiangsu Cancer Hospital, Nanjing
"SBI of Healthcare Oncology Dispensary #2 Ministry of Healthcare of Krasnodar Region", Sochi
Volgograd Regional Clinical Oncology Dispensary, Volgograd
Stanford University School of Medicine - Cancer Institute, Stanford
Cancer Hospital Chinese Academy of Medical Sciences, Beijing
Linyi Cancer Hospital, Linyi
Liaoning Cancer Hospital & Institute, Shenyang
Henan Cancer Hospital, Zhengzhou
"State Budgetary Healthcare Institution of Stavropol Territory Pyatigorsk Interregional Oncology Dispensary", Pyatigorsk
Kryvyi Rih Oncology Dispensary, Kryvyi Rih
Lead Sponsor
Covance
INDUSTRY
ICON plc
INDUSTRY
BeyondSpring Pharmaceuticals Inc.
INDUSTRY