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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541082
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Oncoceutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasms Glioblastoma Gliosarcoma, Adult Anaplastic Oligodendroglioma Anaplastic Astrocytoma Pilocytic Astrocytoma Oligodendroglioma Gliomatosis Cerebri Pleomorphic Xanthoastrocytoma Anaplastic Pleomorphic Xanthoastrocytoma Diffuse Midline Glioma, H3 K27M-Mutant Ependymoma Ependymoma, Anaplastic Medulloblastoma Teratoid Rhabdoid Tumor Neuroectodermal Tumors, Primitive Neuroectodermal Tumors Anaplastic Meningioma Atypical Meningioma Choroid Plexus Neoplasms Pineal Tumor Diffuse Astrocytoma Glial Tumor Drug: ONC206 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ONC206 Drug: ONC206
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


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 28 Days ]
    To determine the MTD of single agent oral ONC206


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years with a recurrent, primary CNS neoplasm. Primary CNS neoplasms included in this study: glioblastoma and glioblastoma histologic subtypes, gliosarcoma, primary CNS sarcomas, anaplastic glial neoplasms including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed neuronal-glial tumors, and pilocytic astrocytoma with anaplastic features, diffuse astrocytoma, oligodendroglioma, gliomatosis cerebri, pleomorphic xanthoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, diffuse midline gliomas and histone mutated gliomas, ependymoma, anaplastic ependymoma, and all ependymoma subtypes, medulloblastoma and all medulloblastoma subtypes, ATRT, primary CNS embryonal/primitive neuroectodermal tumors, atypical and anaplastic meningiomas, choroid plexus tumors, and pineal region tumors.
  • Advanced disease after having received established standard of care treatment for their disease and have no standard treatment options available
  • Karnofsky Performance Score (KPS) of greater than or equal to 70.
  • Measurable or evaluable disease defined by RANO criteria. The exception will be patients who have had surgery in the past 4 weeks, patients who are post-operative after a maximal resection will be allowed to enroll after 4 weeks from surgical resection.
  • Washout for prior investigational or approved cytotoxic chemotherapy is 28 days prior to the first dose of ONC206; 42 days in the case of nitrosoureas; 28 days or 5 half-lives (whichever is less; but not less than 14 days) in case of investigational or approved molecularly targeted agent; 14 days in the case of radiotherapy.
  • Patients will be required to enroll on the NCI Neuro-Oncology Branch natural history study (16-C-0151).
  • No major surgery in the prior 4 weeks
  • Patients must have normal organ and marrow function as defined below:
  • An available tumor specimen (paraffin-embedded block and/or frozen tissue) from prior resection or biopsy, ≥15 unstained slides for IHC analysis.
  • Ability to swallow oral capsules.
  • Ability to tolerate an MRI study with intravenous gadolinium contrast.
  • Men and women must use double barrier contraceptives

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 and patients with primary or secondarily generalized seizures in the 28 days before enrollment are excluded. Peri-operative seizures occurring within 7 days of surgery with resolution by day 8 after surgery are allowable. Patients must be on stable doses of one or two seizure medications for 14 days prior to study enrollment.
  • Impairment of gastrointestinal (GI) function
  • Concurrent use of warfarin sodium or other Coumadin-derivative anti-coagulants
  • Concurrent use of strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9 and 2C19 are excluded at least 14 days prior to and throughout the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541082


Contacts
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Contact: Clinical Operations Oncoceutics 1-844-ONCORXS info@oncoceutics.com

Locations
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United States, Maryland
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kelly Mentges, RN, CEN, MSN    240-760-7126    Kelly.mentges@nih.gov   
Sponsors and Collaborators
Oncoceutics, Inc.
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Mark Gilbert, MD National Institutes of Health (NIH)
More Information
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Responsible Party: Oncoceutics, Inc.
ClinicalTrials.gov Identifier: NCT04541082    
Other Study ID Numbers: ONC206-01
NIH 20C0069 ( Other Identifier: National Institutes of Health )
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oncoceutics, Inc.:
Glioblastoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Diffuse Astrocytoma
Oligodendroglioma
Additional relevant MeSH terms:
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Neoplasms
Glioblastoma
Astrocytoma
Ependymoma
Meningioma
Gliosarcoma
Oligodendroglioma
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Rhabdoid Tumor
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Choroid Plexus Neoplasms
 Pinealoma
Glioma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Complex and Mixed
Cerebral Ventricle Neoplasms
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases