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Arm II - ONC201 treatment only for Meningioma
Phase 1
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of ONC201 concentration in resected meningioma tissue
Evaluation of progression-free survival (PFS)
Secondary outcome measures
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 2021 Phase 2 trial • 30 Patients • NCT0339402760%
Fatigue
40%
Alkaline phosphatase increased
40%
Aspartate aminotransferase increased
40%
Lymphocyte count decreased
40%
Dizziness
30%
Alanine aminotransferase increased
30%
Diarrhea
20%
Hypophosphatemia
20%
Abdominal pain
20%
Anemia
20%
Nausea
20%
Dyspnea
10%
Sepsis
10%
Lethargy
10%
Proteinuria
10%
Pain
10%
Vaginal discharge
10%
Paresthesia
10%
Pleural effusion
10%
Vaginal hemorrhage
10%
Edema limbs
10%
Flu like symptoms
10%
Gastroesophageal reflux disease
10%
Headache
10%
Atrial flutter
10%
Cardiac arrest
10%
Dehydration
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
10%
Sinus tachycardia
10%
Stroke
10%
Thromboembolic event
10%
Urinary tract infection
10%
Anorexia
10%
Arthralgia
10%
Back pain
10%
Constipation
10%
Lymphedema
10%
Malaise
10%
Mucosal infection
10%
Myalgia
10%
Rash maculo-papular
10%
Rhinorrhea
10%
Vascular access complication
10%
Weight loss
10%
Cough
10%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3-Endometrial Cancer (Female Only)
Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)
Cohort 2-Triple Negative Breast Cancer (Male and Female)
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
537 Previous Clinical Trials
1,143,927 Total Patients Enrolled
ChimerixIndustry Sponsor
41 Previous Clinical Trials
4,112 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Arm I - Presurgical?
"The safety of Arm I - Presurgical has been rated a 1, since this is the first stage of clinical trials and there are still limited data confirming its efficacy and safety."
Answered by AI
Is participation in this medical research still a viable option for individuals?
"Unfortunately, this medical trial is not currently enrolling patients. Initially posted on January 1st 2024 and last updated August 21st 2023, the study has since closed its doors to new participants. However, there are 47 other clinical trials that remain open for enrollment at present."
Answered by AI
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