Recurrent Malignant GliomaPhase 1OKN-007NCT01672463
Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
A Phase 1 study testing OKN-007 in people with Recurrent Malignant Glioma, run by Oblato, Inc. at 1 site in United States.
Trial summary
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Malignant Glioma
- What is being tested?
- OKN-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2023
- Phase
- Phase 1
- 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 histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
- Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
- Prior radiotherapy
- Prior Temozolomide treatment
- Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
- Karnofsky performance status greater than or equal to 60%
Show all 15Show fewer
- Full recovery (< grade 1) from the toxic effects of 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
- Total bilirubin within normal limits
- AST / ALT (SGPT) <2.5 x ULN
- Creatinine within normal limits
- Patients must be >_18 years of age
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.
- Patients with PT/PTT above the upper limit of normal
- Screening ECG abnormality documented by the investigator as medically significant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. 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 with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
- Conditions
- Recurrent Malignant Glioma
- Being tested
- OKN-007
- 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
Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled in this study Receives: Drug: OKN-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events per patient
The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.
Measured: 24 months
Secondary outcomes (2)
PK level in participants
To determine drug levels of OKN-007 in blood.
Measured: 24 months
6 month progression-free survival
To determine radiographic response rate and 6 month Progression-Free Survival (PFS) of patients treated with OKN-007. PFS is defined as the time from first drug treatment until objective tumor progression or death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startDec 2012
- Primary completion31 Jan 2023
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Malignant GliomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oblato, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Battiste, MD, PhD, Principal investigator, • Oklahoma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672463
- Sponsor's protocol ID
- HCI57337
- Acronym
- OKN-007
- Status last verified
- Mar 2023
- First submitted
- 21 Aug 2012
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT01672463
- Acronym / sponsor ID
- OKN-007 / HCI57337
- Conditions
- Recurrent Malignant Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Oblato, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Aug 2012 (estimated)
- 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 an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. 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 with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: OKN-007All participants enrolled in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
- Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
- Prior radiotherapy
- Prior Temozolomide treatment
- Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
Key exclusion criteria (7 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)
- Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
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-007Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter. Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter. | Drug | All patients |
Primary outcome
Number of Adverse events per patient
Time frame: 24 months
The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.
2 secondary outcomes
PK level in participants
Time frame: 24 months
6 month progression-free survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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, PhD principal investigator
• Oklahoma University
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 in people with Recurrent Malignant Glioma, run by Oblato, Inc. 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 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
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?
Number of Adverse events per patient (time frame: 24 months). 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 29 Mar 2023.