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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization up to 44 months
Awards & highlights
Pivotal Trial
Summary
This trial will test if a new drug can improve survival for people with a specific type of brain tumor who have had radiation therapy.
Who is the study for?
This trial is for patients with a new diagnosis of H3 K27M-mutant diffuse glioma who have finished standard radiotherapy. They must understand the study, weigh at least 10 kg, and have stable health status. Exclusions include recent use of certain drugs like Temozolomide or Bevacizumab, evidence of disease spread beyond the brain, abnormal lab results, pregnancy, or any condition that could affect safety or compliance.
What is being tested?
The ACTION Study tests whether ONC201 can extend survival after radiotherapy in patients with H3 K27M-mutant diffuse glioma. It's a Phase 3 trial where participants are randomly assigned to receive either ONC201 plus placebo or just placebo in a double-blind manner (neither doctors nor patients know who gets the drug).
What are the potential side effects?
While specific side effects for ONC201 aren't listed here, common side effects from cancer treatments may include fatigue, nausea, blood count changes increasing infection risk and potential allergic reactions to medication components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization up to 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up to 44 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Progression free survival (PFS) as assessed by using RANO-HGG criteria
Secondary study objectives
Change from baseline in clinical laboratory parameters
Corticosteroid response
Incidence of adverse events
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ONC201 Twice Weekly GroupExperimental Treatment1 Intervention
Group II: ONC201 Once Weekly GroupExperimental Treatment1 Intervention
Group III: Placebo GroupPlacebo Group1 Intervention
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Who is running the clinical trial?
ChimerixLead Sponsor
41 Previous Clinical Trials
3,637 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my radiotherapy 2 to 6 weeks ago.I have had a detailed MRI scan of my brain before starting radiotherapy.My weight is at least 10 kg.I started radiotherapy within 3 months after being diagnosed with a specific brain tumor mutation.I have new cancer spots not in the area that was radiated.My dose of corticosteroids or anti-seizure medications has been stable or decreasing for the last week.My cancer has spread to the lining of my brain or spinal cord.I have received proton therapy for brain cancer.I have received initial radiotherapy treatment.I have completed a specific course of radiotherapy.I have undergone whole-brain radiotherapy.I do not have any other types of cancer.My brain tumor is newly diagnosed and has a specific genetic mutation (H3 K27M).I am mostly able to care for myself and carry out daily activities.My cancer is a specific type that started in the brain stem.I've had a detailed brain scan after my initial radiotherapy.My cancer originated in my spine.I understand the study and agree to participate by signing a consent form.I haven't used specific cancer treatments recently.
Research Study Groups:
This trial has the following groups:- Group 1: ONC201 Twice Weekly Group
- Group 2: ONC201 Once Weekly Group
- Group 3: Placebo Group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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