Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. 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. 2. 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). 3. 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. 4. For patients with unresected recurrent tumor, unequivocal radiographic evidence of tumor progression by MRI as per the RANO1 criteria within 21 days prior to the first dose. These patients must have at least one measurable lesion per RANO. 5. 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). 6. Eastern Cooperative Oncology Group (ECOG) performance status <2. 7. 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. 8. 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:
- - Leukocytes ≥3.0 × 10^9/L.
- - Absolute neutrophil count (ANC) ≥1.5 × 10^9/L.
- - Platelets ≥100 × 10^9/L.
- - Hemoglobin ≥ 9.0 g/dL.
- - Total bilirubin ≤1.5 × upper limit of normal (ULN), unless documented Gilbert's syndrome.
- - Aspartate transaminase/alanine transaminase ≤2.5 × ULN.
- - Creatinine clearance ≥60 mL/min calculated as per Cockcroft-Gault equation.
Exclusion Criteria:1. 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. 2. 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. 3. Have received chemotherapeutic agents (including TMZ) within 28 days or within 5 half-lives for non-cytotoxic agents (whichever is shorter) of study registration. 4. Serious concomitant systemic disorders, for example, abnormal electrocardiogram (ECG) indicative of cardiac disease (patients with Fridericia-corrected QT interval [QTcF] >450 msec if male and QTcF >470 msec if female. 5. Patients with abnormal sodium, potassium, or creatinine levels grade ≥2. 6. Inability to comply with protocol or study procedures. 7. Women who are pregnant or breastfeeding. 8. Patients who have received bevacizumab for recurrent glioblastoma or are planning to initiate treatment with bevacizumab for tumor necrosis. 9. Patients completing radiotherapy treatment less than 2 weeks prior to planned study treatment initiation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|High-grade Glioma, Oligodendroglioma, Astrocytoma, Glioblastoma Multiforme|
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.
Experimental: Low-dose OKN-007, two times a day (BID)
Dose Escalation Cohort 1
Experimental: Low-dose OKN-007, three times a day (TID)
Dose Escalation Cohort 2
Experimental: Mid-dose OKN-007, three times a day (TID)
Dose Escalation Cohort 3
Experimental: High-dose OKN-007, three times a day (TID)
Dose Escalation Cohort 4
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.