2025-12-17
minor
Study Status, Contacts/Locations v15
Re-verified, no change to tracked fields
2025-07-30
minor
Study Status, Contacts/Locations v12
Re-verified, no change to tracked fields
2025-02-06
minor
Study Status, Contacts/Locations v11
Primary completion date2024-09→2025-12
Completion date2025-02→2026-12
Study sitescontacts updated at 1 of 1 site
Show 10 earlier versions
2024-04-18
minor
Study Status, Eligibility v10
Eligibility criteria+6 characters
[...] eligible.
(Inclusion Criterion #4 was removed in Amendment 3.)
Patients must not have received prior investigational or a [...] ularly targeted agent; 14 days in the case of radiotherapy.
Patients(Inclusion willCriterion be#6 requiredwas toremoved enrollin onAmendment the NCI NOB natural history study (Study 16-C-01517.).
Patients with AEs Grade ≥2 related to prior therapies (chem [...] lobin ≥9.0 mg/dL without transfusion in 2 prior weeks.
Total bilirubin within normal range.
For patients with liver metastases, serum bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert's syndrome may be incl [...] [...]
2023-10-24
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
Eligibility criteria+7,430 characters
Inclusion Criteria:
AgePatients must meet all the following criteria to participate in the study:
Patients aged ≥18 years with a recurrent, primary CNS neoplasm.
For all cohorts, patients must have a histologically confirmed primary CNS neoplasm.
Primary CNS neoplasms included in this study include, but are not limited to, the following: glioblastoma and glioblastoma histologic subtypes, gliosar [...] ocytoma, diffuse midline gliomas and histone mutated gliomas (NOTE: Patients with H3 K27M-mutant diffuse gliomas are excluded unless the primary tumor is located in the pons or spinal cord, or the patie [...] [...]
Primary endpoints1 to 2 entries
Maximum Tolerated Dose (MTD) of single-agent, oral ONC206
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
Study description+4,874 characters
This is a Phase I, open-label, dose-escalation, and exploratory study of ONC206 in patients with recurrent, primary CNS neoplasms.
All patients will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.
There wi [...]
2022-03-01
minor
Study Status, Contacts/Locations v8
Re-verified, no change to tracked fields
2022-02-22
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria+1,132 characters
[...] subtypes, medulloblastoma and all medulloblastoma subtypes, ATRTatypical teratoid/rhabdoid tumor, primary CNS embryonal/primitive neuroectodermal tumors, at [...] ningiomas, choroid plexus tumors, and pineal region tumors.
AdvancedPatients must have recurrent and measurable disease as defined by RANO criteria, using either the HGG and/or low-grade glioma (LGG) RANO criteria based on tumor type, after having received established standard of care treatmen [...] eir disease and have no standard treatment options available as determined by the investigators.
There is no limit on the number of total recurrences [...] [...]
Study sitescontacts updated at 1 of 1 site
2021-04-12
minor
Study Identification, Study Status, Sponsor/Collaborators v6
Lead sponsorOncoceutics, Inc.→Jazz Pharmaceuticals
2020-11-02
minor
Study Status v5
Start dateestimated 2020-10→confirmed 2020-10-26
2020-10-15
minor
Study Status, Conditions, Eligibility v4
Eligibility criteria+2,309 characters
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 anap [...]
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 e [...] [...]
2020-10-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2020-09→2020-10
Study sitesdetails revised at 1 of 1 site
2020-09-17
notable
Recruiting→Not Yet Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Not Yet Recruiting
Study sitesdetails revised at 1 of 1 site
2020-09-08
minor
Study Identification, Study Status, Conditions v1
Study title-78 characters
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