← Back to Search

Imipridone DRD2 Antagonist

ONC201 for Brain Tumor

Phase 2
Waitlist Available
Research Sponsored by Chimerix
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 through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ONC201, a pill that targets proteins, in adults with recurring aggressive brain cancer. It works by blocking a protein that helps cancer cells grow. ONC201 has shown anti-cancer activity in various types of cancer.

Eligible Conditions
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate

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%
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)

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 BExperimental Treatment1 Intervention
ONC201 in relapsed H3 K27M glioma, excluding: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/Kg * Tumors with known 1p/19q co-deletion.
Group II: Arm AExperimental Treatment1 Intervention
ONC201 in relapsed H3 K27M glioma
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?

ChimerixLead Sponsor
41 Previous Clinical Trials
3,992 Total Patients Enrolled

Media Library

ONC201 (Imipridone DRD2 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03295396 — Phase 2
Brain Tumor Research Study Groups: Arm A, Arm B
Brain Tumor Clinical Trial 2023: ONC201 Highlights & Side Effects. Trial Name: NCT03295396 — Phase 2
ONC201 (Imipridone DRD2 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03295396 — Phase 2
~12 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top