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Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Low-dose OKN-007, two times a day (BID)
- Group 2: Low-dose OKN-007, three times a day (TID)
- Group 3: Mid-dose OKN-007, three times a day (TID)
- Group 4: High-dose OKN-007, three times a day (TID)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this research study accepting participants at the present time?
"The details on clinicaltrials.gov indicate that the trial is presently recruiting participants. The original posting date was December 5th 2022 and recently modified at February 8th 2023."
Has the FDA granted permission to administer High-dose OKN-007 at a dosage of three times daily?
"Since High-dose OKN-007, administered three times a day (TID) is in Phase 1 of its clinical trial process, there are limited data supporting safety and efficacy. As such, the drug received score of one on our team's scale assessing risk factors."
What is the scope of participation in this experiment?
"Confirmatively, the information provided on clinicaltrials.gov indicates that this experiment is actively searching for participants. This study was initially published on December 5th 2022 and has been revised most recently on February 8th 2023. The trial requires 16 volunteers to be sourced from 2 individual sites."
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What portion of applicants met pre-screening criteria?
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