NCT06134765

Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer

A Multi-cohort, Open-label, Multicenter Exploratory Clinical Study of Bemalenograstim Alfa for the Prevention of Reduced ANC in Patients With Colorectal Cancer/Pancreatic Cancer Following a Bi-weekly Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-cohort, open-label, multicenter exploratory clinical study of Bemalenograstim alfa for the prevention of reduced absolute neutrophil count(ANC) in patients with colorectal cancer/pancreatic cancer following a bi-weekly chemotherapy regimen.A total of 89 patients are planned to be enrolled.

Detailed description

This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.

Conditions

• Colorectal Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Bemalenograstim alfa	Bemalenograstim alfa,20mg, once every treatment

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-10-30
• Completion: 2025-03-30
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: China