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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
ACTION 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.Check my eligibility
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).See study design
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.
ACTION Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Progression free survival (PFS) as assessed by using RANO-HGG criteria
Secondary outcome measures
Change from baseline in clinical laboratory parameters
Corticosteroid response
Incidence of adverse events
+2 moreACTION 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
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
3,689 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a high risk for people in the ONC201 Twice Weekly Group?
"ONC201 Twice Weekly Group's safety is estimated to be a 3. This is due to Phase 3 data supporting efficacy as well as multiple rounds of data that suggest ONC201 Twice Weekly Group is safe."
Answered by AI
If a patient meets the requirements, can they enroll in this clinical trial right away?
"Yes, as of today's date, the clinical trial is still searching for participants. The original posting was on November 15th, 20202 and has not been edited since. They are looking for 450 patients from a single location."
Answered by AI
What is the projected volume of people who will be participating in this clinical trial?
"The clinicaltrials.gov website indicates that this study is still seeking patients. This particular trial was first posted on November 15th, 2020 and last updated on the same date. There is a goal to enroll 450 people total, at a single location."
Answered by AI
If this clinical trial is successful, what will be its most significant accomplishments?
"The sponsor of this study, Chimerix, is measuring the primary outcome of Progression free survival (PFS) using the RANO-HGG criteria. This will be assessed over a period of 44 months. Additionally, the trial will also assess secondary outcomes including Incidence of adverse events, Corticosteroid response, and PFS using RANO-HGG criteria."
Answered by AI
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