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ONC201 for Meningioma
Phase 2
Waitlist Available
Led By Nicole Shonka, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a new treatment for brain tumors. Patients will receive surgery or study drug depending on their situation. Goal is to measure drug in tumor tissue & time until tumor gets worse or death.
Who is the study for?
Adults with a brain tumor called meningioma who have either not had surgery yet or have no more treatment options after prior therapy can join. They must be in stable health, with proper liver and kidney function, and cannot be on certain medications that affect the heart or liver enzymes. Women of childbearing age and men must agree to use contraception.
What is being tested?
The trial is testing ONC201's effectiveness for treating meningiomas. Participants are divided into two groups: those undergoing surgery and those without further treatment options. The study measures drug levels in removed tumors and tracks how long patients live without their tumor worsening.
What are the potential side effects?
Specific side effects of ONC201 aren't listed here, but participants will be monitored for any adverse reactions due to the medication which could include typical drug-related issues like nausea, fatigue, allergic reactions or changes in blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluation of ONC201 concentration in resected meningioma tissue
Evaluation of progression-free survival (PFS)
Secondary study objectives
Correlation of DRD2 expression with tumor response
Evaluation of the efficacy of adding bevacizumab to ONC201 following disease progression
Evaluation of tumor response from ONC201 on imaging
Side effects data
From 2023 Phase 2 trial • 30 Patients • NCT0303420030%
Hypercalcemia
30%
Pain
20%
Anemia
20%
Fatigue
20%
Hypotension
20%
Headache
20%
Creatinine increased
10%
Dizziness
10%
Urticaria
10%
Anxiety
10%
Gastroesophageal reflux disease
10%
Dyspnea
10%
Surgical and medical procedures - Other, specify - Exploratory laparotomy of abdomen
10%
Hypertension
10%
Chills
10%
Hot flashes
10%
Hypophosphatemia
10%
Fall
10%
Leukocytosis
10%
Edema face
10%
Fever
10%
General disorders and administration site conditions - Other, specify - Hives
10%
Bloating
10%
Bone pain
10%
Investigations - Other, specify: Aspartate aminotransferase decreased
10%
Neuralgia
10%
Insomnia
10%
Nausea
10%
Vascular disorders - Other, specify: Diaphoresis
10%
Sore throat
10%
Alkaline phosphatase increased
10%
Atrial Flutter
10%
Diarrhea
10%
Cardiac disorders - Other, specify: Abnormal EKG
10%
Syncope
10%
Fracture
10%
Aspartate aminotransferase increased
10%
Serum sickness
10%
Brachial plexopathy
10%
Ascites
10%
General disorders and administration site conditions - Other, specify: Hives
10%
General disorders and administration site conditions - Other, specify: Neck swelling
10%
Cognitive disturbance
10%
Dysgeusia
10%
Flatulence
10%
Platelet count decreased
10%
General disorders and administration site conditions - Other, specify: Facial swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Metastatic PC-PG
Arm B: Other NETs
Arm C: PC-PG + Other NETs
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II - ONC201 treatment onlyExperimental Treatment1 Intervention
Participants will receive one dose of ONC201 per week until progression. ONC201 is taken by mouth at 625 mg per dose.
Group II: Arm I - PresurgicalExperimental Treatment1 Intervention
Participants who will be undergoing surgery to remove their meningioma will receive two doses of ONC201 prior to their surgery. ONC201 is taken by mouth at 625 mg per dose. ONC201 will be taken once per week with the second dose taken approximately 24 hours prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONC201
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,359 Total Patients Enrolled
ChimerixIndustry Sponsor
41 Previous Clinical Trials
4,060 Total Patients Enrolled
1 Trials studying Meningioma
102 Patients Enrolled for Meningioma
Nicole Shonka, MDPrincipal InvestigatorUniversity of Nebraska
5 Previous Clinical Trials
91 Total Patients Enrolled