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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: Active Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nader Sanai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tumor to plasma partition coefficients of niraparib for total (Kp) and unbound (Kp,uu) drug levels
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 |
What the registry record for NCT05076513 still lists
NCT05076513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (61% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05076513's enrollment target sits among peer trials
42 102nd of 199 higher than 98 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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