Clinical Trials /

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

NCT04541082

Description:

The primary objective of this phase 1 trial is to determine the maximum tolerated dose (MTD), food effect, safety and tolerability of oral ONC206 in patients with recurrent, primary CNS neoplasms.

Related Conditions:
  • Central Nervous System Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ONC206-01
  • SECONDARY ID: NIH 20C0069
  • NCT ID: NCT04541082

Conditions

  • Central Nervous System Neoplasms

Interventions

DrugSynonymsArms
ONC206ONC206

Purpose

The primary objective of this phase 1 trial is to determine the maximum tolerated dose (MTD), food effect, safety and tolerability of oral ONC206 in patients with recurrent, primary CNS neoplasms.

Trial Arms

NameTypeDescriptionInterventions
ONC206Experimental
  • ONC206

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years with a recurrent, primary CNS neoplasm

          -  Advanced disease after having received established standard of care treatment

          -  Karnofsky Performance Score (KPS) of greater than or equal to 70

          -  Measurable or evaluable disease defined by RANO criteria

          -  Normal organ and marrow function

          -  Ability to swallow oral capsules.

        Exclusion Criteria:

          -  Prior bevacizumab for treatment of high-grade glioma

          -  Known HIV-positive test on combination antiretroviral therapy

          -  Active cardiac disease

          -  Ischemic or hemorrhagic stroke in last 3 months

          -  Refractory epilepsy, seizures in the 28 days prior to study enrollment

          -  Impairment of gastrointestinal (GI) function
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose
Time Frame:28 Days
Safety Issue:
Description:To determine the MTD of single agent oral ONC206

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Oncoceutics, Inc.

Trial Keywords

  • Glioblastoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Diffuse Astrocytoma
  • Oligodendroglioma

Last Updated

September 8, 2020