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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor: Jazz Pharmaceuticals
Study ID: NCT04541082
Phase: PHASE1
Status: Recruiting

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Conditions

Anaplastic Astrocytoma
Anaplastic Meningioma
Anaplastic Oligodendroglioma
Anaplastic Pleomorphic Xanthoastrocytoma
Atypical Meningioma
Central Nervous System Neoplasms
Choroid Plexus Neoplasms
Diffuse Astrocytoma
Diffuse Midline Glioma, H3 K27M-Mutant
Ependymoma
Ependymoma, Anaplastic
Glial Tumor
Glioblastoma
Gliomatosis Cerebri
Gliosarcoma, Adult
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Oligodendroglioma
Pilocytic Astrocytoma
Pineal Tumor
Pleomorphic Xanthoastrocytoma
Teratoid Rhabdoid Tumor

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

ONC206 — DRUG
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.

Study Details

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.