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Small Molecule

ONC206 for Brain Cancer

Phase 1

Recruiting

Led By Mark Gilbert, MD

Research Sponsored by Chimerix

Eligibility Criteria Checklist

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

Must have

Patients aged ≥18 years with a recurrent, primary CNS neoplasm with histologically confirmed primary CNS neoplasm including various subtypes

Patients must have normal organ and marrow function as defined

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what dose is safe and how it is affected by food.

Who is the study for?

Adults over 18 with recurrent brain tumors, who are in good physical condition (KPS ≥70), have normal organ/marrow function, and haven't had recent chemotherapy or major surgery. They must be able to swallow pills or liquids, consent to the study, test negative for COVID-19, provide a tumor sample, undergo MRI with contrast, and have measurable disease. Pregnant women and those on certain drugs or with specific medical conditions can't participate.Check my eligibility

What is being tested?

The trial is testing ONC206's safety at different doses for treating various types of recurring brain tumors. It's an early-stage study where patients take oral ONC206 either once weekly or multiple times a week to find the highest dose they can tolerate without severe side effects.See study design

What are the potential side effects?

While not explicitly listed in the provided information since this is a Phase I trial primarily focused on determining safe dosage levels, potential side effects may include typical reactions such as nausea, fatigue, digestive issues but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 and have a confirmed brain tumor that has come back.

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My organ and bone marrow functions are normal.

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My cancer has returned and can be measured, with no further standard treatments available.

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I am mostly able to care for myself.

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I haven't had experimental or standard chemotherapy recently.

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All my side effects from previous treatments have resolved.

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I can swallow pills or liquids without difficulty.

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I can provide a sample of my tumor from a previous surgery or biopsy.

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I can undergo an MRI with contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days 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 single-agent, oral ONC206

Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ONC206Experimental Treatment1 Intervention

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

ChimerixLead Sponsor

41 Previous Clinical Trials

4,037 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,397 Total Patients Enrolled

Mark Gilbert, MDPrincipal InvestigatorNational Institutes of Health (NIH)

1 Previous Clinical Trials

92 Total Patients Enrolled

Media Library

ONC206 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04541082 — Phase 1

Brain Tumor Research Study Groups: ONC206

Brain Tumor Clinical Trial 2023: ONC206 Highlights & Side Effects. Trial Name: NCT04541082 — Phase 1

ONC206 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541082 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI