NCT06251947

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).

Detailed description

This study is a single-arm, multicenter clinical trial. A total of 83 patients will be enrolled, including 55 patients with primary epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and 28 patients with primary or recurrent/metastatic cervical cancer in the first-line setting. 1\) Ovarian Cancer Chemotherapy regimen (Paclitaxel + Carboplatin ± Bevacizumab): Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin Area under the curve 5(AUC5), intravenous infusion over 1 hour, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks. (2) Cervical Cancer Chemotherapy regimen (Paclitaxel + Carboplatin/Cisplatin ± Bevacizumab): Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin AUC5, intravenous infusion over 1 hour, on day 1, or Cisplatin 50-80mg/m2, intravenous infusion over 1-3 hours, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks. Efbemalenograstim Alfa should be administered subcutaneously, 20mg per injection, within 24-48 hours after the completion of each chemotherapy cycle.

Conditions

• Ovarian Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Efbemalenograstim Alfa	Efbemalenograstim Alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Timeline

• Start date: 2024-04-15
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-02-09
• Last updated: 2024-05-07

Locations

6 sites across 1 country: China