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Stress Response Inducer

ONC206 + Radiation Therapy for Brain Tumor (PNOC023 Trial)

Q: Are there any antecedent tests involving ONC206?

ONC206 was initially studied in 2011 at Valme University Hospital, with 65 studies since completed. Currently 14 active trials are underway throughout the world, particularly in San Francisco, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: What conditions typically respond favorably to ONC206 treatments?

ONC206 is frequently used to address hypotension caused by trauma, <a href="https://www.withpower.com/clinical-trials/sepsis">sepsis</a>, cardiac surgery and renal failure as well as illnesses such as myocardial infarction, <a href="https://www.withpower.com/clinical-trials/cystic-fibrosis">cystic fibrosis</a> (cf) and arrhythmia.

Q: What efficacy goals is this trial hoping to accomplish?

This medical experiment intends to observe the frequency of dose-limiting toxicities (DLT) during a 4 week period post first dosage. Secondary objectives include analyzing the mean total body clearance, peak concentration time, and area under curve for ONC206 through population PK methodologies as well as non-linear mixed effect modeling.

Q: How many individuals are participating in this medical trial?

Correct. According to clinicaltrials.gov, this trial is still open for recruitment and was last updated on September 13th 2022; it first appeared online on August 23rd 2021. A total of 256 patients need to be enrolled across two medical centres.

Q: Does this empirical inquiry encompass elderly participants aged 85 or more?

According to the eligibility parameters, only patients between 2 and 21 years old are allowed to join this trial. On a larger scale, 572 trials target minors while 3754 clinical studies encompass people older than 65.

Q: Is enrollment for this clinical experiment still available to participants?

According to clinicaltrials.gov, this medical experiment is actively in search of volunteers and was first publicized on August 23rd 2021 with an update occurring one year later.

Q: Has this specific trial been conducted before in medical history?

Research into the benefits of ONC206 has been ongoing since 2011, when Boehringer Ingelheim first sponsored a trial involving 60 patients. This study resulted in N/A approval for the medication and today there are 14 active studies with locations spanning 43 cities across 15 countries.

Q: What adverse effects could patients encounter from ONC206 treatments?

The safety profile of ONC206 is rated at 1 due to the limited clinical data available from its Phase 1 trials, which provide little information on efficacy and safety.

Q: What are the eligibility criteria for taking part in this research?

This clinical trial seeks 256 young patients ranging from 2 to 21 suffering from <a href="https://www.withpower.com/clinical-trials/glioblastoma">glioblastoma</a>. <a href="https://www.withpower.com/clinical-trials/all">All</a> participants must meet the following criteria: Arm A- Patients who have completed at least one line of prior therapy, including radiation and cannot show evidence of disease progression; Arm B- Newly diagnosed sufferers with a confirmed diagnosis or DMG (H3K27M mutant) or WHO grade III/IV H3 wildtype gliomas; Arm C- Suffers that are experiencing an initial relapse but has not been treated yet and is recommended for reirradiation. Additionally, all arms need to be free of acute effects caused by

Phase 1

Recruiting

Research Sponsored by Sabine Mueller, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TARGET VALIDATION: Children and young adults with recurrent primary malignant CNS tumors, including recurrent DMG, who have evidence of progression but have not been treated for this progression

Serum creatinine < 1.5 Upper Limit normal (ULN) based on age and gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)

Awards & highlights

PNOC023 Trial Summary

This trial is studying the effects and best dose of ONC206 given alone or with radiation therapy in treating patients with newly diagnosed or recurrent diffuse midline gliomas or other recurrent primary malignant CNS tumors.

Who is the study for?

This trial is for children and adults with newly diagnosed or recurrent diffuse midline gliomas (DMG) and other malignant CNS tumors. Participants must have stable vital signs, not be pregnant or breastfeeding, agree to use contraception if applicable, and cannot be on certain medications that affect ONC206 absorption or immune system disorders.Check my eligibility

What is being tested?

The trial is testing the effectiveness of a new drug called ONC206 alone or combined with standard radiation therapy. The goal is to find the best dose that can stop tumor growth by triggering a stress response in cancer cells without harming normal cells.See study design

What are the potential side effects?

Potential side effects of ONC206 are not detailed here but may include reactions related to the body's stress response to treatment. Standard radiation therapy side effects typically include fatigue, skin irritation at the treatment site, and potential hair loss.

PNOC023 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has a recurring brain tumor that has progressed but hasn't been treated for this progression.

Select...

My kidney function, measured by creatinine, is within the normal range for my age and gender.

Select...

I am newly diagnosed with a specific brain tumor showing certain genetic changes.

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I am willing to provide tissue samples for the study.

Select...

My previous tests confirmed I have a malignant brain tumor.

Select...

My tumor is confirmed as DMG, H3K27 altered by a pathology test.

Select...

My tumor is confirmed to have a specific genetic change known as DMG, H3K27 altered.

Select...

I am a young person newly diagnosed with a specific brain or spinal tumor.

PNOC023 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) of ONC206

Proportion of participants with dose-limiting toxicities (DLT)

Secondary outcome measures

Area under the curve (AUC) of ONC206

Elimination half-life (t1/2) of ONC206

Mean Total body clearance (CL) for ONC206

+3 more

PNOC023 Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progressionExperimental Treatment1 Intervention

Patients receive ONC206 PO once a day (QD) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreatedExperimental Treatment2 Interventions

Patients undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group III: Arm B: ONC206 + radiation therapy for newly diagnosed participantsExperimental Treatment2 Interventions

Group IV: Arm A: ONC206 for participants with diffuse midline gliomas + prior therapyExperimental Treatment1 Intervention

Patients receive ONC206 orally (PO) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

The ChadTough Defeat DIPG FoundationUNKNOWN

Storm the Heavens FundUNKNOWN

1 Previous Clinical Trials

143 Total Patients Enrolled

Sabine Mueller, MD, PhDLead Sponsor

8 Previous Clinical Trials

227 Total Patients Enrolled

Media Library

ONC206 (Stress Response Inducer) Clinical Trial Eligibility Overview. Trial Name: NCT04732065 — Phase 1

Diffuse Midline Glioma Research Study Groups: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progression, Arm B: ONC206 + radiation therapy for newly diagnosed participants, Arm A: ONC206 for participants with diffuse midline gliomas + prior therapy, Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreated

Diffuse Midline Glioma Clinical Trial 2023: ONC206 Highlights & Side Effects. Trial Name: NCT04732065 — Phase 1

ONC206 (Stress Response Inducer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732065 — Phase 1

Frequently Asked Questions

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

Are there any antecedent tests involving ONC206?

"ONC206 was initially studied in 2011 at Valme University Hospital, with 65 studies since completed. Currently 14 active trials are underway throughout the world, particularly in San Francisco, California."

Answered by AI

What conditions typically respond favorably to ONC206 treatments?

"ONC206 is frequently used to address hypotension caused by trauma, sepsis, cardiac surgery and renal failure as well as illnesses such as myocardial infarction, cystic fibrosis (cf) and arrhythmia."

Answered by AI

What efficacy goals is this trial hoping to accomplish?

"This medical experiment intends to observe the frequency of dose-limiting toxicities (DLT) during a 4 week period post first dosage. Secondary objectives include analyzing the mean total body clearance, peak concentration time, and area under curve for ONC206 through population PK methodologies as well as non-linear mixed effect modeling."

Answered by AI

How many individuals are participating in this medical trial?

"Correct. According to clinicaltrials.gov, this trial is still open for recruitment and was last updated on September 13th 2022; it first appeared online on August 23rd 2021. A total of 256 patients need to be enrolled across two medical centres."

Answered by AI

Does this empirical inquiry encompass elderly participants aged 85 or more?

"According to the eligibility parameters, only patients between 2 and 21 years old are allowed to join this trial. On a larger scale, 572 trials target minors while 3754 clinical studies encompass people older than 65."

Answered by AI

Is enrollment for this clinical experiment still available to participants?

"According to clinicaltrials.gov, this medical experiment is actively in search of volunteers and was first publicized on August 23rd 2021 with an update occurring one year later."

Answered by AI

Has this specific trial been conducted before in medical history?

"Research into the benefits of ONC206 has been ongoing since 2011, when Boehringer Ingelheim first sponsored a trial involving 60 patients. This study resulted in N/A approval for the medication and today there are 14 active studies with locations spanning 43 cities across 15 countries."

Answered by AI

What adverse effects could patients encounter from ONC206 treatments?

"The safety profile of ONC206 is rated at 1 due to the limited clinical data available from its Phase 1 trials, which provide little information on efficacy and safety."

Answered by AI

What are the eligibility criteria for taking part in this research?

"This clinical trial seeks 256 young patients ranging from 2 to 21 suffering from glioblastoma. All participants must meet the following criteria: Arm A- Patients who have completed at least one line of prior therapy, including radiation and cannot show evidence of disease progression; Arm B- Newly diagnosed sufferers with a confirmed diagnosis or DMG (H3K27M mutant) or WHO grade III/IV H3 wildtype gliomas; Arm C- Suffers that are experiencing an initial relapse but has not been treated yet and is recommended for reirradiation. Additionally, all arms need to be free of acute effects caused by"

Answered by AI

Recent research and studies

Neuro-OncologyJournal

Imipridones Affect Tumor Bioenergetics and Promote Cell Lineage Differentiation in Diffuse Midline Gliomas

Przystal, Justyna M, Chiara Cianciolo Cosentino, Sridevi Yadavilli, Jie Zhang, Sandra Laternser, Erin R Bonner, Rachna Prasad, et al.. 2022. “Imipridones Affect Tumor Bioenergetics and Promote Cell Lineage Differentiation in Diffuse Midline Gliomas”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noac041.

Neuro-OncologyJournal

Imipridones Affect Tumor Bioenergetics and Promote Cell Lineage Differentiation in Diffuse Midline Gliomas

clinicaltrials.govStudy

ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors

Sabine Mueller, MD, PhD 2021. "ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732065.

All > Ependymoma > Glioblastoma Multiforme