NCT03294577 - Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia | Biotech Hunter

Enrollment

221

Participants

Timeline

Start Date

October 23, 2019

Primary Completion Date

September 25, 2020

Study Completion Date

September 25, 2025

Conditions

Chemotherapy-induced Neutropenia

Interventions

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

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).

OTHER

D5W Placebo

Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W

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 (20)

25011

Kirovograd Regional Oncological Center, Kropyvnytskyi

49102

Dnipropetrovsk City Multifunctional Hospital #4 Oncology Department, Dnipro

50048

Public Institution Kryvyi Rih Oncology Center, Krivoy Bereg

65025

Odessa regional clinical hospital Thoracic Surgery Department Academician Zabolotnoho, Odesa

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

Unknown

No. 1 Banshandong Road, Hangzhou

Cancer Center of Guangzhou Medical University, Guangzhou

Prykarpatskiy Regional Oncological Center, Ivano-Frankivsk

Regional Clinical Oncology Center, Kharkiv

V.T. Zaycev Institute, Kharkiv

Hemotherapy Department, Kyiv

Kyiv City Clinical Oncological Center, Kyiv

Lviv State Oncological Regional, Lviv

Zakarpattia Regional Clinical Oncology Center, Uzhhorod

Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsia

Zaporizhia Regional Clinical Oncology Dispensary, Zaporizhzhya