Spots Global Cancer Trial Database for Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma

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Trial Identification

Brief Title: Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma

Official Title: A Phase 1b Open-Label Study Investigating the Tolerability, Safety, and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma

Study ID: NCT05561374

Conditions

High-grade Glioma

Oligodendroglioma

Astrocytoma

Glioblastoma Multiforme

Interventions

Low-dose OKN-007, BID

Low-dose OKN-007, TID

Mid-dose OKN-007, TID

High-dose OKN-007, TID

Study Description

Brief Summary: This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.

Detailed Description: This phase 1 open-label study is based on the traditional 3+3 design following the initial single-participant cohort to determine the maximum tolerated dose (MTD). Eligible participants will be enrolled each of the cohorts with escalated dose levels and administered the study drug OKN-007 orally daily in 28-day cycles: Cohort 1, Cohort 2, Cohort 3, Cohort 4. Participants may receive study treatment up to 2 years or until tumor progression, unacceptable toxicity, death, or patient withdrawal. The safety and pharmacokinetic properties of oral OKN-007 will be investigated.