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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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 2021 Phase 2 trial • 30 Patients • NCT03394027

60%

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%

Edema limbs

10%

Paresthesia

10%

Vaginal discharge

10%

Pain

10%

Sepsis

10%

Lethargy

10%

Vaginal hemorrhage

10%

Proteinuria

10%

Pleural effusion

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%

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)

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

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