GlioblastomaPhase 1NCT03587038
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
A Phase 1 study testing OKN 007, Temozolomide and Photon/Proton IMRT in people with Glioblastoma, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- OKN 007, Temozolomide and Photon/Proton IMRT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
- Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
- Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
- ECOG performance status within 0 - 2
- Full recovery (< grade 1) from the adverse events associated with prior surgery or any earlier intervention and a minimum of 28 days from the administration of any investigational agent
- Adequate renal, liver and bone marrow function: Leukocytes >3,000/mcL; Absolute neutrophil count >1,500/mcL; Platelets >100,000/mcL; AST / ALT (SGPT) <2.5 x ULN; Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL); Creatinine within normal limits
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- Patients must be ≥ 18 years of age
- Patients must be willing to have blood draws for PK analysis
- All patients must have a CT or MRI of the brain within 14 days prior to registration. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
- Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and progression-free survival evaluation;
- Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
- Male patient agrees to use an adequate method of contraception
- Birth control should be used from the signing of the patient consent form and for 120 days following the last dose of study treatment.
- In addition, men must not donate sperm during study therapy and for 120 days after receiving the last dose of study treatment.
Who cannot join
- Second primary malignancy (except adequately treated basal cell carcinoma of the skin).
- Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
- 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
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
- Patients with moderate or severe renal impairment (calculated creatinine clearance of < 60 mL/min)
- Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
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- Screening ECG abnormality documented by the investigator as medically significant
- Inability to comply with protocol or study procedures.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.
- Conditions
- Glioblastoma
- Being tested
- OKN 007, Temozolomide, Photon/Proton IMRT
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKN 007Drug
400 mg OKN-007/mL in a phosphate buffer
TemozolomideDrug
75 mg/m2
Photon/Proton IMRTRadiation
standard of care treatment to be given 1 to 2 hours after OKN-007
| Study group | Role | What they receive |
|---|---|---|
| OKN-007 3 days per week plus temozolomide | Experimental | OKN-007: 60 mg/kg, IV, 3 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions Receives: Drug: OKN 007; Drug: Temozolomide; Radiation: Photon/Proton IMRT |
| OKN-007 5 days per week and temozolomide | Experimental | OKN-007: 60 mg/kg, IV, 5 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions Receives: Drug: OKN 007; Drug: Temozolomide; Radiation: Photon/Proton IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose and the type of dose limiting toxicities
To determine how well patients are able to tolerate combination of OKN-007, temozolomide, and radiotherapy. Adverse events will be tabulated using MedDRA. The severity of the AE will be graded by the Investigator using the NCI CTCAE, version 4.03.
Measured: 5 years
Secondary outcomes (4)
Number of participants who experience progression-free survival
To evaluate the proportion of patients who receive combination OKN-007 and TMZ who do not experience progression
Measured: 5 years
Number of participants who comply with study treatment plan
To evaluate the clinical compliance of participants receiving combination OKN-007 and TMZ
Measured: 5 years
Number of participants who are able to receive a reduction in steroid dose
To evaluate whether study drug combination allows for a reduced steroid dosage
Measured: 5 years
Number of participants who experience overall survival
To evaluate the proportion of patients who receive combination OKN-007 and TMZ who experience overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start3 Sep 2018
- Primary completion23 Dec 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Battiste, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587038
- Sponsor's protocol ID
- OU-SCC-Oblato-001
- Other IDs
- OKN-007
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03587038
- Acronym / sponsor ID
- OU-SCC-Oblato-001
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OKN-007 3 days per week plus temozolomide | Experimental | Drug: OKN 007, Drug: Temozolomide, Radiation: Photon/Proton IMRTOKN-007: 60 mg/kg, IV, 3 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions |
| OKN-007 5 days per week and temozolomide | Experimental | Drug: OKN 007, Drug: Temozolomide, Radiation: Photon/Proton IMRTOKN-007: 60 mg/kg, IV, 5 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
- Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
- Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
- ECOG performance status within 0 - 2
- Full recovery (< grade 1) from the adverse events associated with prior surgery or any earlier intervention and a minimum of 28 days from the administration of any investigational agent
Key exclusion criteria (9 listed)
- Second primary malignancy (except adequately treated basal cell carcinoma of the skin).
- Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
- 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
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
- Patients with moderate or severe renal impairment (calculated creatinine clearance of < 60 mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKN 007400 mg OKN-007/mL in a phosphate buffer | Drug | OKN-007 3 days per week plus temozolomide, OKN-007 5 days per week and temozolomide |
| Temozolomide75 mg/m2 | Drug | OKN-007 3 days per week plus temozolomide, OKN-007 5 days per week and temozolomide |
| Photon/Proton IMRTstandard of care treatment to be given 1 to 2 hours after OKN-007 | Radiation | OKN-007 3 days per week plus temozolomide, OKN-007 5 days per week and temozolomide |
Primary outcome
The maximum tolerated dose and the type of dose limiting toxicities
Time frame: 5 years
To determine how well patients are able to tolerate combination of OKN-007, temozolomide, and radiotherapy. Adverse events will be tabulated using MedDRA. The severity of the AE will be graded by the Investigator using the NCI CTCAE, version 4.03.
4 secondary outcomes
Number of participants who experience progression-free survival
Time frame: 5 years
Number of participants who comply with study treatment plan
Time frame: 5 years
Number of participants who are able to receive a reduction in steroid dose
Time frame: 5 years
Number of participants who experience overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Battiste, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OKN 007, Temozolomide and Photon/Proton IMRT in people with Glioblastoma, run by University of Oklahoma at 1 site 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 15 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The maximum tolerated dose and the type of dose limiting toxicities (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.