RecruitingPhase 1NCT04541082

Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms


Sponsor

Jazz Pharmaceuticals

Enrollment

102 participants

Start Date

Oct 26, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase (Phase 1) study is testing the safety and tolerability of an oral drug called ONC206 in patients with brain tumors (primary central nervous system tumors) that have come back after previous treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of a recurrent primary brain tumor — including glioblastoma, anaplastic glioma, diffuse midline glioma, or other related tumors - You have received prior standard treatment (usually radiation and/or chemotherapy) - Your general health and organ function are adequate to tolerate the study drug **You may NOT be eligible if...** - This is your first diagnosis (not a recurrence) - You have significant uncontrolled medical conditions - You are on medications that strongly interact with the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONC206

ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors.


Locations(1)

National Institutes of Health

Bethesda, Maryland, United States

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NCT04541082


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