NCT04715620

Niraparib Combined With Radiotherapy in rGBM

Efficacy and Safety of Niraparib Combined With Radiotherapy in Patients With Recurrent Glioblastoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight \<77Kg or baseline platelet count \<150,000/µL), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight \<77Kg or baseline platelet count \<150,000/µL)

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2021-01-20
• Last updated: 2021-01-20

Locations

1 site across 1 country: China