Plinabulin iv Solution in Prevention of TAC Induced Neutropenia

PHASE2CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

October 15, 2018

Study Completion Date

January 3, 2019

Conditions
Chemotherapy-induced Neutropenia
Interventions
DRUG

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).

DRUG

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.

DRUG

Docetaxel, doxorubicin, and cyclophosphamide (TAC)

Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent.

Trial Locations (11)

25011

Kirovograd Regional Oncological Center, Kropyvnytskyi

49102

Dnipropetrovsk City Multifunctional Hospital #4 Oncology Department, Dnipro

50048

Public Institution Kryvyi Rih Oncology Center, Krivoy Bereg

61103

"V.T. Zaycev Institute of General and Urgent Surgery NAMS of Ukraine Dept. of Oncology", Kharkiv

65025

Odessa regional clinical hospital Thoracic Surgery Department Academician Zabolotnoho, Odesa

76000

Prykarpatskiy Regional Oncological Center, Ivano-Frankivsk

110000

Liaoning Cancer Hospital & Institute, Shenyang

130000

China-Japan Union Hospital of Jilin University Tumor department of Hematology, Changchun

150000

Harbin Medical University Cancer Hospital, Harbin

500000

Fourth Hospital of Hebei Medical University Breast cancer department, Shijiazhuang

510000

Cancer Center of Guangzhou Medical University Breast Oncology, Guangzhou

All Listed Sponsors
lead

BeyondSpring Pharmaceuticals Inc.

INDUSTRY

NCT04227990 - Plinabulin iv Solution in Prevention of TAC Induced Neutropenia | Biotech Hunter | Biotech Hunter