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NCT06161519 · ClinicalTrials.gov registry record · Phase 1
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
A Phase 1 study of Glioblastoma and Glioma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 1
- Study location
NCT06161519 is a Phase 1 study of Glioblastoma and Glioma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 146 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (35% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06161519, a Phase 1 study of Glioblastoma and Glioma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years. Many of these people have changes in certain genes (MYC or MYCN) that drive the development of their cancers. Objective: To test a study drug (PLX038) in people with tumors of the brain or spinal cord. Eligibility: People aged 18 years or older with a tumor of the brain or spinal cord. Some participants must also have tumors with changes in the MYC or MYCN genes. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and a test of their heart function. They may need to have a biopsy: A sample of tissue will be removed from their tumor. PLX038 is given through a tube attached to a needle inserted into a vein in the arm. All participants will receive PLX038 on the first day of each 21-day treatment cycle. They will take a second drug 3 days later to help reduce the risk of infection; for this drug, participants will be shown how to inject themselves under the skin at home. Blood tests, imaging scans, and other tests will be repeated during study visits. Hair samples will also be collected during these visits. Some participants may have an additional biopsy. Study treatment will continue up to 7 months. Follow-up visits will continue every few months for up to 5 years.
Conditions Studied
Interventions
- DRUG PLX038
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2033-11-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06161519
The ClinicalTrials.gov registry entry for NCT06161519 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (35% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which PLX038 is the first listed.
NCT06161519 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06161519 about?
NCT06161519 is a clinical study titled "PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications". Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years. Many of these people have ...
What is the current status of trial NCT06161519?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2024-01-31. Estimated completion is 2033-11-14.
What conditions does trial NCT06161519 study?
This clinical trial studies the following conditions: Glioblastoma, Glioma, Medulloblastoma, Ependymoma.
What interventions are being tested in trial NCT06161519?
The interventions under investigation include: PLX038 (DRUG).
Who is sponsoring clinical trial NCT06161519?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06161519 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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