NCT04554056

Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF

A Phase II/III,Multi-Center,Randomized,Double-blind,Active-Controlled Trial to Compare the Efficacy , Safety and Immunogenicity of MW05 and PEG-rhG-CSF in Prophylactic Treatment for Chemotherapy-Induced Neutropenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 586 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 . The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.

Detailed description

Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2. Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	MW05	Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection
DRUG	PEG-rhG-CSF	PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

Timeline

• Start date: 2020-09-21
• Primary completion: 2022-08-20
• Completion: 2022-11-05
• First posted: 2020-09-18
• Last updated: 2022-12-02

Locations

1 site across 1 country: China