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NCT05076513 · ClinicalTrials.gov registry record · Early Phase 1
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
A Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nader Sanai.
- Active
- Registry status
- Early Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT05076513 is a Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme that is active but no longer recruiting, run by Nader Sanai. The registered enrollment target is 42 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05076513, a Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, is active but no longer recruiting, sponsored by Nader Sanai.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- RADIATION Radiation therapy
- DRUG Niraparib
Study Locations (1)
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2027-03 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05076513
The ClinicalTrials.gov registry entry for NCT05076513 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (61% lower). The listed sponsor is Nader Sanai, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Radiation therapy is the first listed.
NCT05076513 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT05076513 about?
NCT05076513 is a clinical study titled "Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma". 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 ...
What is the current status of trial NCT05076513?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 42 participants. The study started on 2021-10-29. Estimated completion is 2027-03.
What conditions does trial NCT05076513 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Glioma, GBM, Glioma, Malignant.
What interventions are being tested in trial NCT05076513?
The interventions under investigation include: Radiation therapy (RADIATION), Niraparib (DRUG).
Who is sponsoring clinical trial NCT05076513?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05076513 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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