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Stress Response Inducer

ONC206 for Gliomas(PNOC023 Trial)

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

ARM C: Children and young adults with DMGs who have evidence of progression but have not been treated for this progression and are recommended to get re-irradiation

Peripheral absolute neutrophil count (ANC) >= 1.0 g/l

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upday 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

No Placebo-Only Group

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.

Eligible Conditions

Diffuse Midline Glioma
Gliomas
Glioblastoma
Brain Tumor
Spinal Cord Glioma
Ependymoma

PNOC023 Trial Eligibility Criteria

Inclusion Criteria

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

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Children and young adults with a certain type of brain tumor showing signs of getting worse, who have not yet received treatment for this worsening, and are advised to have radiation therapy again.

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Your blood test shows you have enough infection-fighting white blood cells.

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You are willing to provide enough tissue for the study.

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For group A, it is required to confirm the type of tumor by testing the tissue for specific genetic changes.

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You need to have a tissue sample from your tumor that shows it is a specific type called DMG with a certain genetic change.

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Your liver enzyme levels are not more than three times the normal limit.

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Children and young adults with a specific type of brain tumor who have received treatment in the past, including radiation therapy, and are within 4-14 weeks from completing radiation therapy.

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Children and young adults who have been recently diagnosed with a specific type of brain tumor called DMG with a specific genetic change are eligible. This also includes DMGs in the spinal cord.

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You have had targeted radiation treatment as part of your initial therapy, and it has been at least 6 months since your last radiation treatment.

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Children and young adults with recurring brain tumors that have started growing again and have not received treatment for this growth.

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You need to have had a previous test to confirm that your tumor is in the brain, and the results should show that it is cancerous.

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People with newly discovered brain tumors that show certain changes in their DNA are allowed to join the study.

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Children and young adults with recurring brain tumors who have not received treatment for their latest progression.

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If you are taking steroids, the dose should not be increasing for at least 3 days before the MRI scan.

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Your platelet count is at least 100 billion per liter of blood, and you have not needed a blood transfusion for at least 7 days before joining the study.

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Your kidney function, as measured by a blood test, should be within a certain range based on your age and gender.

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Your bilirubin levels must be within a certain range, depending on your age and health condition. If you have Gilbert's syndrome, there are different limits for your bilirubin levels.

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Your AST levels are not more than three times the normal upper limit.

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You have a seizure disorder that is well-managed.

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If you are older than 16, your Karnofsky score needs to be at least 50. If you are 16 or younger, your Lansky score needs to be at least 50.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,492 Previous Clinical Trials

41,267,328 Total Patients Enrolled

Sabine Mueller, MD, PhDLead Sponsor

8 Previous Clinical Trials

212 Total Patients Enrolled

ChimerixIndustry Sponsor

41 Previous Clinical Trials

3,842 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 , 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.

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