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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will be administered low doses of oral OKN-007 two times a day daily in 28-day cycles.
Participants will be administered low doses of oral OKN-007 three times a day daily in 28-day cycles.
Participants will be administered mid doses of oral OKN-007 three times a day daily in 28-day cycles.
Providence Saint John's Cancer Institute
Santa Monica, California, United States
Norton Healthcare
Louisville, Kentucky, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
The University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Safety and tolerability: Adverse events
Safety and tolerability will be evaluated from adverse events as reported according to CTCAE version 5.0.
Time frame: From Day 1 to 30 days after the last treatment
Pharmacokinetic profile: Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) will be calculated using the actual sample collection times.
Time frame: Pre-dose, 2 hours, 4 hours, 5 hours, 6 hours, and 8 hours post-dose on Days 1 in Cycle 1 and 2; 5 hours post-dose on Day 5; Pre-dose, 5 hours post-dose on Day 8 in Cycle 1; Pre-dose on Days 1 of Cycle 3 and 4 (each cycle is 28 days)
Pharmacokinetic profile: Time to Cmax (Tmax)
Time to Cmax (Tmax) will be calculated using the actual sample collection times.
Time frame: Pre-dose, 2 hours, 4 hours, 5 hours, 6 hours, and 8 hours post-dose on Days 1 in Cycle 1 and 2; 5 hours post-dose on Day 5; Pre-dose, 5 hours post-dose on Day 8 in Cycle 1; Pre-dose on Days 1 of Cycle 3 and 4 (each cycle is 28 days)
Pharmacokinetic profile: Area under the curve (AUC)
Area under the curve (AUC) will be calculated using the actual sample collection times.
Time frame: Pre-dose, 2 hours, 4 hours, 5 hours, 6 hours, and 8 hours post-dose on Days 1 in Cycle 1 and 2; 5 hours post-dose on Day 5; Pre-dose, 5 hours post-dose on Day 8 in Cycle 1; Pre-dose on Days 1 of Cycle 3 and 4 (each cycle is 28 days)
Pharmacokinetic profile: Half-life time (t1/2)
Half-life time (t1/2) will be calculated using the actual sample collection times.
Time frame: Pre-dose, 2 hours, 4 hours, 5 hours, 6 hours, and 8 hours post-dose on Days 1 in Cycle 1 and 2; 5 hours post-dose on Day 5; Pre-dose, 5 hours post-dose on Day 8 in Cycle 1; Pre-dose on Days 1 of Cycle 3 and 4 (each cycle is 28 days)
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Participants will be administered high doses of oral OKN-007 three times a day daily in 28-day cycles.