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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

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.

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%
Vaginal hemorrhage
10%
Sepsis
10%
Edema limbs
10%
Vaginal discharge
10%
Lethargy
10%
Pain
10%
Paresthesia
10%
Pleural effusion
10%
Proteinuria
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 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 Sep 2025
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