Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Gr… (NCT05561374) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
United States16 participantsStarted 2023-04-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed recurrent gliomas that were originally diagnosed as high-grade glioma (World Health Organization \[WHO\] Grade 3 or 4; astrocytoma, oligodendroglioma, or glioblastoma) by histopathology or molecular studies.
. Progressive or recurrent gliomas documented by magnetic resonance imaging (MRI) no earlier than 180 days after first surgery for gliomas and no earlier than 90 days after completion of radiotherapy (applies to patients with first progression/recurrence only).
. Patients must have medical records available documenting known histology or molecular and genetic information resulting from prior analyses, or tumor tissue samples available from prior glioma surgery or open biopsy for correlative research.
. For patients with unresected recurrent tumor, unequivocal radiographic evidence of tumor progression by MRI as per the RANO criteria within 28 days prior to the first dose. These patients must have at least one measurable lesion per RANO.
. No more than two prior lines of therapy for high-grade glioma (WHO Grade 3 or 4). The first-line therapy must include radiotherapy (minimum of 50 Gy; 34 Gy in elderly patients) with concomitant or adjuvant standard chemotherapy (temozolomide (TMZ), or procarbazine, lomustine and vincristine in patients with anaplastic oligodendroglioma).
. Eastern Cooperative Oncology Group (ECOG) performance status \<2.
. Full recovery (grade ≤1) from the toxic effects of any earlier intervention and a minimum of 28 days from the last administration of any investigational agent that has not received regulatory approval for any indication at the time of registration.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability: Adverse events
Timeframe: From Day 1 to 30 days after the last treatment
2
Pharmacokinetic profile: Maximum plasma concentration (Cmax)
Timeframe: 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)
3
Pharmacokinetic profile: Time to Cmax (Tmax)
Timeframe: 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)
4
Pharmacokinetic profile: Area under the curve (AUC)
Timeframe: 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)
5
Pharmacokinetic profile: Half-life time (t1/2)
Timeframe: 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)
. Adequate renal, liver and bone marrow function without packed red blood cell/platelet transfusions within 4 weeks of the date of lab test during screening:
Exclusion criteria
. Prior malignancy (other than glioma) expected to require treatment within a 6-month period (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past but have been free of active disease for more than 2 years, are eligible.
. Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study registration.
. Have received chemotherapeutic agents (including TMZ) within 28 days or within 5 half-lives for non-cytotoxic agents (whichever is shorter) of study registration.
. Serious concomitant systemic disorders, for example, abnormal electrocardiogram (ECG) indicative of cardiac disease (patients with Fridericia-corrected QT interval \[QTcF\] \>480 msec.
. Patients with abnormal sodium, potassium, or creatinine levels grade ≥2.
. Inability to comply with protocol or study procedures.
. Women who are pregnant or breastfeeding.
. Patients who have received bevacizumab for recurrent glioblastoma or are planning to initiate treatment with bevacizumab for tumor necrosis.