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Oral OKN-007 for Brain Tumor

Phase 1
Recruiting
Research Sponsored by Oblato, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status <2
Patients must not have significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do all or most of my daily activities without help.
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I can swallow pills and don't have ongoing severe stomach or bowel problems.
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I am 18 years old or older.
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I have records or samples from my brain tumor for research use.
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I have recovered from previous treatments and it's been over 28 days since my last investigational drug.
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My MRI shows my tumor has grown recently, according to specific criteria.
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My brain tumor is a high-grade glioma that has come back.
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I've had up to 2 treatments for a serious brain tumor and received specific chemo and radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic profile: Area under the curve (AUC)
Pharmacokinetic profile: Half-life time (t1/2)
Pharmacokinetic profile: Maximum plasma concentration (Cmax)
+4 more
Secondary outcome measures
Median Overall Survival (OS) by RANO criteria
Median Progression-Free Survival (PFS) assessed by Radiographic Assessment in Neuro-Oncology (RANO) criteria

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

Find a Location

Who is running the clinical trial?

Oblato, Inc.Lead Sponsor
4 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Astrocytoma

Media Library

OKN-007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05561374 — Phase 1
Astrocytoma Research Study Groups: Low-dose OKN-007, two times a day (BID), Low-dose OKN-007, three times a day (TID), Mid-dose OKN-007, three times a day (TID), High-dose OKN-007, three times a day (TID)
Astrocytoma Clinical Trial 2023: OKN-007 Highlights & Side Effects. Trial Name: NCT05561374 — Phase 1
OKN-007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05561374 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Providence Saint John's Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby May 2024