Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study

PHASE3UnknownINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

February 1, 2021

Study Completion Date

March 30, 2021

Conditions
Solid Tumor Patients Receiving High Emetic Risk Multi-day Chemotherapy
Interventions
DRUG

olanzapine plus fosaprepitant-based triple regimen

olanzapine 5mg p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.

DRUG

placebo plus fosaprepitant-based triple regimen

placebo p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.

Trial Locations (18)

Unknown

Beijing Cancer Hospital, Beijing

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Hunan Cancer Hospital, Changsha

Sichuan Cancer Hospital& Institute, Chengdoucun

The First Affiliated Hospital of Chongqing Medical University, Chongqing

Sun Yat-sen University Cancer Center, Guangdong

Harbin Medical University Cancer Hospital, Haerbin

Anhui Provincial Cancer Hospital, Hefei

Yunnan Cancer Hospital, Kunming

Jiangxi Cancer Hospital, Nanchang

Guangxi Medical University Affiliated Tumor Hospital, Nanning

Ningbo Medical Center Lihuili Hospital, Ningbo

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai

Liaoning Cancer Hospital & Institute, Shenyang

Fourth Hospital of Hebei Medical University, Shijiazhuang

The First Affiliated Hospital of Soochow University, Suzhou

Tianjin Medical University General Hospital, Tianjin

Henan Cancer Hospital, Zhengzhou

All Listed Sponsors
collaborator

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

lead

Sun Yat-sen University

OTHER

NCT04536558 - Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study | Biotech Hunter | Biotech Hunter