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Imipridone DRD2 Antagonist
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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 2023 Phase 2 trial • 30 Patients • NCT0303420030%
Pain
30%
Hypercalcemia
20%
Fatigue
20%
Anemia
20%
Creatinine increased
20%
Headache
20%
Hypotension
10%
Dizziness
10%
Urticaria
10%
Vascular disorders - Other, specify: Diaphoresis
10%
General disorders and administration site conditions - Other, specify: Neck swelling
10%
Serum sickness
10%
Syncope
10%
Fall
10%
Fracture
10%
Sore throat
10%
Leukocytosis
10%
Chills
10%
Edema face
10%
Fever
10%
General disorders and administration site conditions - Other, specify - Hives
10%
Hypophosphatemia
10%
Dyspnea
10%
Surgical and medical procedures - Other, specify - Exploratory laparotomy of abdomen
10%
Alkaline phosphatase increased
10%
Anxiety
10%
Ascites
10%
Aspartate aminotransferase increased
10%
Atrial Flutter
10%
Bloating
10%
Bone pain
10%
Brachial plexopathy
10%
Cognitive disturbance
10%
Diarrhea
10%
Dysgeusia
10%
Flatulence
10%
Gastroesophageal reflux disease
10%
General disorders and administration site conditions - Other, specify: Facial swelling
10%
General disorders and administration site conditions - Other, specify: Hives
10%
Hot flashes
10%
Hypertension
10%
Insomnia
10%
Investigations - Other, specify: Aspartate aminotransferase decreased
10%
Nausea
10%
Neuralgia
10%
Platelet count decreased
10%
Cardiac disorders - Other, specify: Abnormal EKG
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Metastatic PC-PG
Arm B: Other NETs
Arm C: PC-PG + Other NETs
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The main cancer is found in the middle part of the brain (pons) or in the spinal cord.You have had allergic reactions in the past to substances that are similar to ONC201 or its ingredients.The tumor has spread beyond the original area that was treated with high-dose radiation therapy, as determined by the treating investigatorYou currently use illegal drugs or have been diagnosed with alcohol addiction.You are able to swallow and keep medicine in your body when taken by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.