Trials / Active Not Recruiting
Active Not RecruitingNCT05076513
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
A Phase 0 'Trigger' Trial of Niraparib in Newly-diagnosed Glioblastoma and Recurrent IDH1/2(+) ATRX Mutant Glioma
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Nader Sanai · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | 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 | Radiation therapy | Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care. |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2024-03-19
- Completion
- 2027-03-01
- First posted
- 2021-10-13
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05076513. Inclusion in this directory is not an endorsement.