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OKN-007 + Temozolomide for Recurrent Brain Cancer

Phase 2
Waitlist Available
Research Sponsored by Oblato, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with unequivocal radiographic evidence of tumor progression by MRI for unresected recurrent tumor with at least one measurable lesion
Confirmed Glioblastoma based on histopathology or molecular profile analysis (WHO Grade IV) following primary treatment with TMZ and radiotherapy and at least two cycles of maintenance TMZ as first-line or second-line treatment with another regimen excluding bevacizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, OKN-007, to see if it is effective, safe, and has the desired pharmacological properties when combined with the standard chemotherapy drug, temozolomide, in treating patients with recurrent glioblastoma.

Who is the study for?
Adults with recurrent glioblastoma who've had standard treatment including surgery, radiation, and chemotherapy. They must have good organ function and performance status (able to carry out daily activities), no severe side effects from previous treatments, no more than two prior GBM therapies excluding bevacizumab as second line, and a confirmed diagnosis based on tissue analysis.Check my eligibility
What is being tested?
The trial is testing OKN-007 in combination with Temozolomide for safety, effectiveness, and how the body processes it. Participants must show clear signs of tumor recurrence on MRI but should not have received certain other treatments recently or have serious health issues that could interfere.See study design
What are the potential side effects?
Specific side effects are not listed here; however, participants will be monitored for any adverse reactions due to the combination of OKN-007 with Temozolomide. Previous experience suggests potential side effects may include fatigue, nausea, blood count changes among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scans show clear tumor growth, and I have at least one tumor that can be measured.
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My glioblastoma was confirmed and I've had specific treatments but not bevacizumab.
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I have recovered from side effects of previous treatments.
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I am 18 years old or older.
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My medical records show my cancer's MGMT status or I can provide a tissue sample for testing.
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I can take care of myself and am up and about more than half of my waking hours.
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I have had up to two treatments for glioblastoma, but not bevacizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide
Number of subjects with decreased neurological function
Number of subjects with decreased performance
+1 more
Secondary outcome measures
AUC of OKN-007 in blood plasma
AUC of Temozolomide in blood plasma
Cmax of OKN-007 in blood plasma
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All patientsExperimental Treatment2 Interventions
All patients enrolled in this study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide (TMZ)
2005
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Oblato, Inc.Lead Sponsor
4 Previous Clinical Trials
47 Total Patients Enrolled
2 Trials studying Glioblastoma
16 Patients Enrolled for Glioblastoma
Shinwook KangStudy DirectorOblato, Inc.

Media Library

OKN-007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04388475 — Phase 2
Glioblastoma Research Study Groups: All patients
Glioblastoma Clinical Trial 2023: OKN-007 Highlights & Side Effects. Trial Name: NCT04388475 — Phase 2
OKN-007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04388475 — Phase 2

Frequently Asked Questions

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

Have similar tests been conducted previously?

"Schering-Plough first sponsored a study on OKN-007 way back in 2002. Since then, there have been 218 active studies conducted in 36 countries and 947 cities."

Answered by AI

How many places are doing this research?

"Right now, potential patients can go to 11 different sites to enroll in this clinical trial. The locations of these centres are: Providence, Birmingham, Detroit and other places. Depending on where you live, it might be best to choose the closest location to cut down on travel time if you decide to participate."

Answered by AI

Are people still able to join this clinical trial?

"According to clinicaltrials.gov, this trial is no longer recruiting patients for participation. This study was originally posted on June 12th 2020 and was last edited on October 25th 2022. Although this particular trial has closed recruitment, there are 1885 other studies that are still actively recruiting patients."

Answered by AI

Can you please summarize the risks associated with OKN-007?

"OKN-007 falls into the Phase 2 category, meaning that while there is data supporting its safety, there are no studies yet affirming its efficacy. Consequently, Power rates it as a 2 in terms of safety."

Answered by AI

What other research studies have there been on OKN-007?

"Currently, 218 active clinical trials are investigating the efficacy of OKN-007. Among these studies, 25 are in Phase 3. Additionally, while the majority of these trials are located in Seoul and Songpa, there are a total of 4,820 locations conducting these investigations."

Answered by AI

How many people are eligible for this clinical trial?

"This study isn't enrolling patients at the moment. The listing for this clinical trial was first posted on June 12th, 2020 and was last edited on October 25th, 2022. For those seeking other trials, 1667 brain-related studies and 218 OKN-007 related studies are currently looking for participants."

Answered by AI

What is the standard protocol for OKN-007?

"nitrosourea treatment is most commonly treated with OKN-007. However, OKN-007 has also been shown to be effective in treating refractory neuroblastoma, mycosis fungoides, and advanced directives."

Answered by AI
~12 spots leftby Mar 2025