Niraparib Combined With Radiotherapy in rGBM

Sponsor
Tianjin Huanhu Hospital
Study ID
NCT04715620
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jan 31, 2021
Status verified
Jan 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: niraparib

Primary Outcome Measure

PFS-6 [ Time Frame: 6 months ]

Central Contacts

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