NCT03649464

Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants

A Phase Ib/2 Open-label Study Investigating the Tolerability, Safety, Pharmacokinetic Properties and Efficacy of Oral OKN-007 in Participants With Recurrent High-grade Glioma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oblato, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.

Detailed description

Dose escalation/PK study (Phase Ib) will follow a traditional 3+3 design with evaluable participants enrolled at each dose level: Cohort 1 (1000mg, BID), Cohort 2, (1000mg, TID), and Cohort 3 (1500 mg, TID). The food-effect study will be one-week add-on study at the beginning of the dose escalation/PK study. Dose expansion study (Phase 2) will proceed to treat at the maximum tolerated dose (MTD) up to 2 years or until tumor progression, unacceptable toxicity, death or participants withdrawal. Participant may continue receiving treatment beyond 2 years at the discretion of investigator.

Conditions

• Glioblastoma
• Astrocytoma
• Oligodendroglioma

Interventions

Type	Name	Description
DRUG	OKN-007	Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID). Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-04-01
• Completion: 2025-08-01
• First posted: 2018-08-28
• Last updated: 2022-10-07

Regulatory

• FDA-regulated drug study