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NCT04614909 · ClinicalTrials.gov registry record · Early Phase 1
Study of Pamiparib in Newly Diagnosed and rGBM
A Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nader Sanai.
- Active
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04614909: Active Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nader Sanai.
NCT04614909 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 45 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614909, 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
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Participants with tumors demonstrating a PK response in the Phase 0 component of the study will graduate to an exploratory Phase 2 component that combines therapeutic dosing of pamiparib plus fractionated radiotherapy (for unmethylated MGMT promoter newly-diagnosed cases), pamiparib plus fractionated radiotherapy (for recurrent cases) or Olaparib plus fractionated radiotherapy (recurrent cases).
Primary Outcome
Total and unbound pamiparib concentration in enhancing and non-enhancing tumor tissue.
Conditions Studied
Interventions
- DRUG Pamiparib
- DRUG Olaparib
- DRUG Temozolomide
- RADIATION Radiation therapy
Study Locations (1)
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2026-07 |
| Phase | Early Phase 1 |
What the registry record for NCT04614909 still lists
NCT04614909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Pamiparib is the first listed.
NCT04614909 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04614909 about?
NCT04614909 is a clinical study titled "Study of Pamiparib in Newly Diagnosed and rGBM". This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Participants w...
What is the current status of trial NCT04614909?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2021-01-11. Estimated completion is 2026-07.
What conditions does trial NCT04614909 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult.
What interventions are being tested in trial NCT04614909?
The interventions under investigation include: Pamiparib (DRUG), Olaparib (DRUG), Temozolomide (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT04614909?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04614909 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 NCT04614909's enrollment target sits among peer trials
45 97th of 199 higher than 101 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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