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ONC206 for Brain Cancer
Study Summary
This trial is testing a new cancer drug to see what dose is safe and how it is affected by food.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a heart condition that is currently causing symptoms.I am HIV-positive and on combination anti-retroviral therapy.I haven't had major surgery in the last 4 weeks and have fully recovered from any past surgeries.I am over 18 and have a confirmed brain tumor that has come back.My organ and bone marrow functions are normal.I am currently on a cancer treatment plan.You have had allergic reactions to drugs that are similar to ONC206.I am a woman who can have children and I have a negative pregnancy test.I have a stomach or intestine condition that affects how my body absorbs medicine.I have a history of heart problems.My cancer has returned and can be measured, with no further standard treatments available.I have not taken strong medication affecting liver enzymes in the last 14 days.I am mostly able to care for myself.I am willing and able to follow the study rules and work with the research team.I haven't had experimental or standard chemotherapy recently.All my side effects from previous treatments have resolved.I can swallow pills or liquids without difficulty.I have not taken ONC201 or similar drugs for my H3 K27M-mutant diffuse glioma since January 2023.I can provide a sample of my tumor from a previous surgery or biopsy.I can undergo an MRI with contrast.I am not pregnant or breastfeeding.I have had a stroke in the past 3 months.I have epilepsy that doesn't respond to treatment or I've had recent seizures.I haven't taken any blood cell growth boosters in the last 2 weeks.I am currently on blood thinners like warfarin.
- Group 1: ONC206
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the highest capacity for participants in this clinical trial?
"Affirmative. According to the clinicaltrials.gov database, this research is presently recruiting participants, with an original post date of October 26th 2020 and last update on March 1st 2022. 102 individuals need to be recruited from a single site."
Is access to this clinical trial available for those seeking treatment?
"According to information on clinicaltrials.gov, this medical trial is still open for enrollment. The posting initially went live on October 26th 2020 and was most recently updated on March 1st 2022."
Has the Federal Drug Administration approved ONC206 for medicinal use?
"At this time, ONC206's safety can only be rated a 1 due to the limited clinical data available from Phase 1 trials."
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