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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug to treat brain tumor in people, to see if it's safe, how it works, and how well it works.
Who is the study for?
Adults with recurrent high-grade gliomas (WHO Grade 3 or 4) who have had no more than two prior treatments, including radiotherapy and chemotherapy. Participants must be in good physical condition (ECOG <2), not pregnant, willing to use contraception, and able to swallow oral medications. They should have adequate organ function and a life expectancy of at least three months.
What is being tested?
The trial is testing different doses of an oral drug called OKN-007 taken either twice or three times daily for safety and how the body processes it. It's open-label, meaning everyone knows what treatment they're getting, and involves multiple centers where patients are being studied.
What are the potential side effects?
Specific side effects aren't listed here but generally could include gastrointestinal issues due to the oral nature of the medication, potential liver or kidney problems as these organs process drugs, fatigue from treatment burden, or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pharmacokinetic profile: Area under the curve (AUC)
Pharmacokinetic profile: Half-life time (t1/2)
Pharmacokinetic profile: Maximum plasma concentration (Cmax)
+2 moreSecondary study objectives
Median Overall Survival (OS) by RANO criteria
Median Progression-Free Survival (PFS) assessed by Radiographic Assessment in Neuro-Oncology (RANO) criteria
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Mid-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention
Dose Escalation Cohort 3
Group II: Low-dose OKN-007, two times a day (BID)Experimental Treatment1 Intervention
Dose Escalation Cohort 1
Group III: Low-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention
Dose Escalation Cohort 2
Group IV: High-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention
Dose Escalation Cohort 4
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Who is running the clinical trial?
Oblato, Inc.Lead Sponsor
4 Previous Clinical Trials
88 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My brain tumor has grown or come back, confirmed by an MRI.I am not pregnant or breastfeeding.I have taken or am planning to take bevacizumab for brain cancer.I agree to use effective contraception or practice abstinence.I have records or samples from my brain tumor for research use.I am 18 years old or older.I've had up to 2 treatments for a serious brain tumor and received specific first-line therapy.I finished my radiotherapy less than 2 weeks ago.I have been treated with an experimental drug within the last 28 days.I haven't taken chemotherapy or similar drugs within the last 28 days or 5 half-lives, whichever is shorter.My kidney, liver, and bone marrow are working well without needing blood transfusions in the last 4 weeks.I am HIV positive, on effective treatment, and my viral load has been undetectable for the last 6 months.I have records or samples from my brain tumor for research use.My digestive system is healthy and I can take pills without trouble.I agree to use effective contraception or practice abstinence during and for 4 months after the study.I am not pregnant, can take a pregnancy test, and will use birth control or abstain from sex during the study.My brain tumor is a high-grade glioma that has come back.I've had up to 2 treatments for a serious brain tumor and received specific chemo and radiation.I can swallow pills and don't have ongoing severe stomach or bowel problems.I can do all or most of my daily activities without help.My MRI shows my tumor has grown recently, according to specific criteria.My MRI shows my tumor has grown recently, according to specific criteria.I have had cancer before, but I've been free of it for over 2 years, except for skin cancer which was treated.I have recovered from previous treatments and it's been over 28 days since my last investigational drug.My brain tumor is a high-grade glioma that has come back.My blood, liver, and kidney functions are within normal ranges without recent transfusions.I can do all my daily activities without help.I am 18 years old or older.I have recovered from previous treatments and it's been over 28 days since my last investigational drug dose.My brain tumor has grown or come back, confirmed by an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Low-dose OKN-007, two times a day (BID)
- Group 2: Low-dose OKN-007, three times a day (TID)
- Group 3: High-dose OKN-007, three times a day (TID)
- Group 4: Mid-dose OKN-007, three times a day (TID)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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