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MEK Inhibitor

Selumetinib + Vinblastine for Low-Grade Glioma

Phase 3
Recruiting
Led By Daniel C Bowers
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is investigating whether adding vinblastine to selumetinib improves treatment of recurrent or progressive low-grade glioma in children and young adults.

Who is the study for?
This trial is for children and young adults aged 2-21 (up to 25 in some phases) with low-grade glioma that's recurrent or progressive after treatment. Participants must have had prior therapy, a body surface area of at least 0.5 m^2, stable organ function, no severe allergies to the drugs being tested, controlled blood pressure, and the ability to swallow capsules.Check my eligibility
What is being tested?
The study compares two treatments: Selumetinib alone versus a combination of Selumetinib and Vinblastine. It aims to find out if adding Vinblastine improves outcomes for patients with low-grade glioma that has returned or isn't responding well to other treatments.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from Vinblastine; skin rash, eye problems like blurred vision from Selumetinib; as well as potential liver issues and high blood pressure which could be caused by either drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (efficacy)
Vinblastine
Secondary outcome measures
EFS by BRAF Status
Incidence of adverse events (efficacy)
Incidence of adverse events (feasibility)
+4 more

Side effects data

From 2020 Phase 2 trial • 8 Patients • NCT03040986
100%
Alanine aminotransferase increased
100%
Hypertension
100%
Aspartate aminotransferase increased
100%
Flatulence
100%
Pruritus
100%
Rash maculo-papular
50%
Hyperglycemia
50%
Hypercalcemia
50%
Hypoalbuminemia
50%
Gastroesophageal reflux disease
50%
Edema limbs
50%
Edema face
50%
Hypocalcemia
50%
Abdominal distension
50%
Dyspnea
50%
Platelet count decreased
50%
Neutrophil count decreased
50%
Paresthesia
50%
Fatigue
50%
Sore throat
50%
Muscle weakness trunk
100%
80%
60%
40%
20%
0%
Study treatment Arm
75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily
Dose Level 0: 75mg Selumetinib Sulfate Twice Daily

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)Experimental Treatment6 Interventions
Patients receive vinblastine sulfate IV over 1 minute or IV infusion on days 1, 8, 15, and 22 and selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days. Patients receive selumetinib and vinblastine for a total duration of 17 cycles followed by 10 additional cycles of selumetinib alone in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
Group II: Efficacy Phase Arm II (selumetinib)Active Control5 Interventions
Patients receive selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Selumetinib Sulfate
2017
Completed Phase 2
~80
Biospecimen Collection
2004
Completed Phase 2
~1720
Vinblastine Sulfate
2007
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,101 Total Patients Enrolled
141 Trials studying Astrocytoma
13,317 Patients Enrolled for Astrocytoma
Daniel C BowersPrincipal InvestigatorChildren's Oncology Group

Media Library

Selumetinib Sulfate (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04576117 — Phase 3
Astrocytoma Research Study Groups: Efficacy Phase Arm II (selumetinib), Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)
Astrocytoma Clinical Trial 2023: Selumetinib Sulfate Highlights & Side Effects. Trial Name: NCT04576117 — Phase 3
Selumetinib Sulfate (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576117 — Phase 3
~124 spots leftby Dec 2026