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NCT03581292 · ClinicalTrials.gov registry record · Phase 2
Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations
A Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT03581292: Active Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
NCT03581292 is a Phase 2 study of Glioblastoma and Malignant Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03581292, a Phase 2 study of Glioblastoma and Malignant Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.
Primary Outcome
Compare event free survival to historical data for each stratum. Analysis will be based on a 2-sample, 1 sided logrank test. EFS is measured from time of enrollment to the date of first documented progression, second malignancy, or date of death from any cause, whichever comes first. Subjects who do not have any event will be censored at the last follow-up date.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Veliparib
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2026-10-16 |
| Phase | Phase 2 |
What the registry record for NCT03581292 still lists
NCT03581292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03581292 names 20 study sites across 6 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT03581292 about?
NCT03581292 is a clinical study titled "Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations". This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inh...
What is the current status of trial NCT03581292?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2018-11-06. Estimated completion is 2026-10-16.
What conditions does trial NCT03581292 study?
This clinical trial studies the following conditions: Glioblastoma, Malignant Glioma, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT03581292?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), Veliparib (DRUG).
Who is sponsoring clinical trial NCT03581292?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03581292 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03581292's enrollment target sits among peer trials
38 110th of 199 higher than 89 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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