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Perillyl alcohol

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

Ensayo de NEONC TECHNOLOGIES HOLDINGS, INC. en Glioblastoma.

Más ensayos de: Glioblastoma.

Fase

Fase 1/2

Estado

En marcha, sin reclutar

Participantes

49

previstos

Centros

11

Fin del objetivo primario

nov 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2017.

Lo que ha cambiado

Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.

Qué mide

Phase 1 Primary Outcome: Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (del registro, en inglés) (hasta 6 meses)

Qué se prueba

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis multi-site, Phase 1/2a clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycles until disease progression, death or patient withdraw from study for any reason, whichever occurs first. Version 10 of the protocol changed the inclusion criteria for Phase 2a to limit inclusion to those patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. Prior to the protocol amendment, 4 patients were enrolled who were IDH1 wild-type. Therefore, an additional 28 patients will be recruited for a total of 32 patients enrolled into Phase 2a of this study to have 35 evaluable cases. Version 12 of the protocol expanded the inclusion criteria for Phase 2a to include those patients with progressive or recurrent Grade III Astrocytoma expressing IDH1 mutations. Review of the literature specific to these patients found the same expected time to progression and death. As a result, the number of patients to enroll remains 32 to have 35 evaluable cases.

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Ficha completa en ClinicalTrials.gov (NCT02704858), actualizada en sep 2026.