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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

Study Summary

This trial will test whether a drug called ONC201 can help treat people with a type of brain cancer called glioma.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Sepsis
10%
Lethargy
10%
Proteinuria
10%
Pain
10%
Paresthesia
10%
Pleural effusion
10%
Vaginal hemorrhage
10%
Edema limbs
10%
Vaginal discharge
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
4,044 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study represent a pioneering effort in its field?

"Presently, 28 cities and 4 countries are hosting 9 active ONC201 studies. First developed in 2015 by Oncoceutics Inc., this drug has gone through Phase 1 & 2 approval with the aid of 120 trial participants. Subsequently, four additional research projects have been conducted to further its development."

Answered by AI

What is the scale of participation in this clinical trial?

"This study has concluded its recruitment process; it was initially posted on October 31, 2017 and most recently updated on July 14, 2022. For those still seeking opportunities to participate in a medical trial, 354 trials for glioma are currently enrolling patients while 9 studies require ONC201 participants."

Answered by AI

What prior experiments have been executed with regard to ONC201?

"The initial ONC201 trial commenced in 2015 at the University of Texas MD Anderson Cancer Centre. At present, there are four concluded trials and nine recruiting studies based largely around New york City."

Answered by AI

How many facilities are actively overseeing this clinical research?

"8 cities are currently participating in this research study, with locations including New york, Charlotte and Philadelphia. To reduce the amount of necessary travel for potential participants it is wise to select a trial centre close by."

Answered by AI

Is this research endeavor currently recruiting participants?

"As indicated on clinicaltrials.gov, the recruitment process for this clinical trial has ceased as of July 14th 2022. Originally posted October 31st 2017, no further patients are being enrolled at present; however, 363 other studies remain open to new participants."

Answered by AI

To what extent can exposure to ONC201 be detrimental?

"Our team's evaluation of ONC201's safety is 2, signifying that there exists evidence attesting to its security but no proven efficacy as it is only in the second phase of trials."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
2017. "ONC201 in Adults With Recurrent H3 K27M-mutant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03295396.
~13 spots leftby Apr 2025
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