Trials / Active Not Recruiting
Active Not RecruitingNCT05561374
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
A Phase 1b Open-Label Study Investigating the Tolerability, Safety, and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Oblato, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low-dose OKN-007, BID | Participants will be administered low doses of oral OKN-007 two times a day daily in 28-day cycles. |
| DRUG | Low-dose OKN-007, TID | Participants will be administered low doses of oral OKN-007 three times a day daily in 28-day cycles. |
| DRUG | Mid-dose OKN-007, TID | Participants will be administered mid doses of oral OKN-007 three times a day daily in 28-day cycles. |
| DRUG | High-dose OKN-007, TID | Participants will be administered high doses of oral OKN-007 three times a day daily in 28-day cycles. |
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2025-05-31
- Completion
- 2025-06-30
- First posted
- 2022-09-30
- Last updated
- 2024-11-29
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05561374. Inclusion in this directory is not an endorsement.