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Recurrent Malignant GliomaPhase 2NCT04388475

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

A Phase 2 study testing OKN-007 and Temozolomide (TMZ) in people with Recurrent Malignant Glioma and Brain Glioblastoma, run by Oblato, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OKN-007 and Temozolomide (TMZ)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
13 sitesUnited States
Study dates
12 Jun 2020to 5 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed Glioblastoma based on histopathology or molecular profile analysis (WHO Grade IV), following primary treatment with TMZ and radiotherapy (minimum of 50 Gy) and at least two cycles of maintenance TMZ (5 days of a 28 day cycle) as first-line or second-line treatment with another treatment regimen, excluding bevacizumab.
  • Patients must have medical records available documenting O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status analysis or must have tumor tissue samples available from prior GBM surgery or open biopsy for MGMT status determination.
  • For patients with unresected recurrent tumor, unequivocal radiographic evidence of tumor progression by MRI. These patients must have at least one measurable lesion.
  • Patients with recent resection of recurrent viable tumor are eligible following post-operative MRI perfusion scan with or without measurable lesions.
  • No more than two prior lines of therapy for glioblastoma. Any second-line therapy is acceptable, excluding bevacizumab as second line.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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  • Full recovery (≤ grade 1) from the toxic effects.
  • Adequate renal, liver and bone marrow function:
  • Hemoglobin >9.0 g/dL
  • Leukocytes >3,000/mcL
  • Absolute neutrophil count >1,500/mcL
  • Platelets >100,000/mcL
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • AST (SGOT) / ALT (SGPT) ≤2.5 × ULN
  • Creatinine clearance ≥ 60 mL/min
  • Patients must be ≥18 years of age

Who cannot join

  • Early discontinuation of TMZ in prior line due to treatment related Adverse events (AEs).
  • Second primary malignancy expected to require treatment within a 6 month period (except adequately treated basal cell carcinoma of the skin).
  • 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 entry.
  • Have received chemotherapeutic agents (including temozolomide) within 28 days or within 5 half-lives for non-cytotoxic agents (whichever is shorter) of study entry
  • Serious concomitant systemic disorders
  • Patients with abnormal sodium, potassium, or creatinine levels ≥ grade 2.
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  • Patients with prothrombin time/partial thromboplastin time (PT/PTT) or International normalized ratio (INR) above the ULN.
  • Inability to comply with protocol or study procedures.
  • Patients who have received bevacizumab for recurrent glioblastoma or are planning to initiate treatment with bevacizumab for tumor necrosis. (Past treatment with bevacizumab for tumor necrosis is acceptable).
  • Patients receiving or planning to initiate treatment with the tumor treating fields device (Optune®) (Optune® prior to enrollment is permitted).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • University of Iowa

    Iowa City, Iowa, 52242

  • Norton Healthcare

    Louisville, Kentucky, 40241

  • The University of Oklahoma

    Oklahoma City, Oklahoma, 73117

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Lifespan Office of Research

    Providence, Rhode Island, 02903

  • Providence Saint John's Health Center - John Wayne Cancer Institute

    Santa Monica, California, 90404

  • St. Joseph Hospital of Orange

    Seattle, Washington, 35143

  • The University of Toledo

    Toledo, Ohio, 43606

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.

Being tested
OKN-007, Temozolomide (TMZ)
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OKN-007Drug

    Also called NXY-059, HPN-07

    Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.

  • Temozolomide (TMZ)Drug

    Also called Temodar

    Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.

Study groups in NCT04388475
Study groupRoleWhat they receive
All patientsExperimentalAll patients enrolled in this study
Receives: Drug: OKN-007; Drug: Temozolomide (TMZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide

    Evaluate incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

    Measured: Through study completion up to 24 months

  2. Overall Survival (OS) rate

    Proportion of subjects who are alive after six months of starting treatment. OS is defined as the time from first treatment dose until date of death due to any cause.

    Measured: 6 months

Secondary outcomes (8)

  1. Overall Response Rate (ORR%)

    The proportion of patients with a complete response or partial response to treatment.

    Measured: 24 months

  2. Progression Free Survival (PFS) rate

    Proportion of subjects who are alive and progression free after six months of starting treatment. PFS is defined as the time from first treatment dose until objective tumor progression on the RANO criteria or death.

    Measured: 6 months

  3. Cmax of OKN-007 in blood plasma

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

  4. AUC of OKN-007 in blood plasma

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

  5. Tmax of OKN-007 in blood plasma

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

  6. Cmax of Temozolomide in blood plasma

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

  7. AUC of Temozolomide in blood plasma

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

  8. Tmax of Temozolomide in blood plasma

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

    Measured: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2020
  2. Study start12 Jun 2020
  3. Primary completion8 May 2024
  4. Study completion5 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388475
Sponsor's protocol ID
OKN-007-IV-RMG-201
Status last verified
Aug 2025
First submitted
6 May 2020
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OKN-007 and Temozolomide (TMZ) in people with Recurrent Malignant Glioma and Brain Glioblastoma, run by Oblato, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide (time frame: Through study completion up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04388475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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