Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT05076513
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    In Phase 0, 300mg administered orally QD for 4 days prior to resection. In the Expansion cohort/Maintenance phase, niraparib will be administered as described below: * For patients weighing \<77 kg (\<170 lbs) OR with a platelet count \<150,000/mcL, the recommended dosage is 200 mg taken orally once daily. * For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.
  • Radiation therapy — RADIATION
    Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.

Study Details

This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.

Key Dates

Start date
Oct 29, 2021
Status verified
Mar 2026
Primary completion
Mar 19, 2024
Completion
Mar 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Presumed Newly-Diagnosed glioblastoma
    Participants undergoing resection for a presumed newly-diagnosed glioblastoma (WHO grade 4) will be treated with niraparib for 4 days prior to surgical resection. Participants who proceed to the therapeutic expansion phase of this study will receive niraparib in combination with radiation (60 Gy over 6-7 weeks, as per standard of care). Following radiotherapy, eligible study participants may receive niraparib maintenance treatment.
  • Experimental: Arm B: Recurrent Glioma (Grades II-IV)
    Participants undergoing resection of a recurrent WHO Grade II, III, or IV glioma with IDH1 or IDH2 mutation and ATRX loss will be treated with niraparib for 4 days prior to a planned surgical resection. Participants who proceed to the Expansion cohort will receive niraparib in 28d cycles after surgery.

Primary Outcome Measure

Phase 0 Arm A: Total and unbound niraparib concentration in enhancing and nonenhancing tissue [ Time Frame: Day 4 Intra-operative sample ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-

Find similar trials in Phoenix, AZ

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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