Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04166409 · ClinicalTrials.gov registry record · Phase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
A Phase 3 study of Low Grade Glioma and WHO Grade 2 Glioma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
- 20
- Study locations
NCT04166409 is a Phase 3 study of Low Grade Glioma and WHO Grade 2 Glioma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 170 participants, above the 106-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (60% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04166409, a Phase 3 study of Low Grade Glioma and WHO Grade 2 Glioma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Echocardiography Test
- OTHER Questionnaire Administration
Study Locations (20)
California
- 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
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2020-01-31 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04166409
The ClinicalTrials.gov registry entry for NCT04166409 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (60% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Low Grade Glioma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04166409 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04166409 about?
NCT04166409 is a clinical study titled "A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma". This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not a...
What is the current status of trial NCT04166409?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2020-01-31. Estimated completion is 2030-12-31.
What conditions does trial NCT04166409 study?
This clinical trial studies the following conditions: Low Grade Glioma, WHO Grade 2 Glioma, Low Grade Astrocytoma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma.
What interventions are being tested in trial NCT04166409?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography Test (PROCEDURE), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT04166409?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04166409 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
Similar trials for Low Grade Glioma
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.
-
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
RECRUITING · Phase 3
-
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
A Vaccine Trial for Low Grade Gliomas
RECRUITING · Phase 2
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.