GlioblastomaPhase 1/2NCT03649464
Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants
A Phase 1/2 study testing OKN-007 in people with Glioblastoma and Astrocytoma, run by Oblato, Inc..
Trial summary
The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Astrocytoma, Oligodendroglioma
- What is being tested?
- OKN-007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Aug 2025
- Phase
- Phase 1/2
- 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 histopathology of recurrent gliomas that were originally diagnosed as, Glioblastoma (WHO Grade IV), Astrocytoma (WHO Grade III), or Oligodendroglioma (WHO Grade III). Participants with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be glioblastoma.
- Unequivocal radiographic evidence of tumor progression by MRI as per the RANO criteria within 14 days prior to registration.
- At least one measureable lesion per RANO.
- Prior radiotherapy
- Prior Temozolomide treatment, unless contraindications or intolerance.
- Last cytotoxic chemotherapy or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered).
Show all 16Show fewer
- ECOG performance status of 0, 1 or 2.
- Full recovery (≤ grade 1) from the toxic effects of any earlier intervention and a minimum of 28 days from the last 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 ≤ 1.5 x ULN; AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN; Creatinine clearance ≥ 60 mL/min calculated as per Cockcroft-Gault equation.
- Must be ≥ 18 years of age.
- Life expectancy (as assessed by the Investigator) at least three months.
- Capability of swallowing oral medication (4-6 size 0 capsules twice or thrice a day).
- Have provided verbal and written informed consent.
- Must be willing to have multiple blood draws for PK analysis.
- Female participants, of childbearing potential, must have 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 participants must agree to use an adequate method of contraception.
Who cannot join
- Second primary malignancy expected to require treatment within a 6 month period (except adequately treated basal cell carcinoma of the skin). Participants 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 participants and his/her ability to complete the study.
- with abnormal sodium, potassium, or creatinine levels ≥ grade 2.
- with PT/PTT or INR above the upper limit of normal, unless treated with anticoagulants (e.g. warfarin). In such cases coagulation parameters (INR) should be monitored weekly for the first six weeks of the study.
- Inability to comply with protocol or study procedures.
- Women who are pregnant or breastfeeding.
- For participation in a food effect cohort, uncontrolled Diabetes Type I or uncontrolled Type II (HbA1c > 7 mmol/L assessed locally) as judged by the Investigator.
About this study
Official title: A Phase Ib/2 Open-label Study Investigating the Tolerability, Safety, Pharmacokinetic Properties and Efficacy of Oral OKN-007 in Participants With Recurrent High-grade Glioma
The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.
Read the detailed description
Dose escalation/PK study (Phase Ib) will follow a traditional 3+3 design with evaluable participants enrolled at each dose level: Cohort 1 (1000mg, BID), Cohort 2, (1000mg, TID), and Cohort 3 (1500 mg, TID). The food-effect study will be one-week add-on study at the beginning of the dose escalation/PK study. Dose expansion study (Phase 2) will proceed to treat at the maximum tolerated dose (MTD) up to 2 years or until tumor progression, unacceptable toxicity, death or participants withdrawal. Participant may continue receiving treatment beyond 2 years at the discretion of investigator.
- Conditions
- Glioblastoma, Astrocytoma, Oligodendroglioma
- Being tested
- OKN-007
- Keywords
- recurrent high-grade glioma
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKN-007Drug
Also called Anti-Cancer Agent
Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID).
Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study.
| Study group | Role | What they receive |
|---|---|---|
| OKN-007 | Experimental | Oral OKN-007 Receives: Drug: OKN-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with DLTs (Dose Limiting Toxicities) and AEs (Adverse Events)
It will be summarized by dose cohort and by overall safety evaluable population using CTCAE v5.0 for Phase Ib dose escalation and Phase 2 dose expansion cohort.
Measured: 28 days
Number of Participants with Best Overall Response Rate in the brain
The rate of participants with complete response of partial response using Response Assessment in Neuro-Oncology Criteria (RANO) will be summarized for Phase 2 dose expansion cohort.
Measured: 24 months
Secondary outcomes (7)
Proportion of Participants as Assessed by 6-month Progression-Free Survival (PFS)
Proportion of participants who are progression free after six months will be calculated for Phase Ib dose escalation and Phase 2 dose expansion cohort.
Measured: 6 months
Proportion of Participants as Assessed by Overall Survival (OS)
Proportion of participants who are alive will be calculated as the time (days) from Day 1 to the participant's death for Phase Ib dose escalation and Phase 2 dose expansion cohort.
Measured: 24 months
The Cmax of OKN-007 in plasma
Blood samples will be collected at 10 time points during the 47.5 hours for Phase Ib dose escalation cohort.
Measured: Day 1 and Day 14
The Tmax (time to maximum concentration) of OKN-007 in plasma
Blood samples will be collected at 10 time points during the 47.5 hours for Phase Ib dose escalation cohort.
Measured: Day 1 and Day 14
AUC (area under the time curve) of OKN-007 in plasma
Blood samples will be collected at 10 time points during the 47.5 hours for Phase Ib dose escalation cohort.
Measured: Day 1 and Day 14
Plasma concentration of OKN-007
Blood samples will be collected for participants enrolled in Phase 2 expansion cohort.
Measured: Before the first dose on Day 8 and before the first dose of Day 29 in the morning
OKN-007 plasma levels over time for food-effect study
Blood samples will be collected on prior to dosing and at the following samples after OKN-007 single dose during 47.5 hours for participants enrolled in the food-effect study in Phase Ib dose escalation cohort.
Measured: Day 7 and Day 4 before the beginning of the dose escalation/PK study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startAug 2022 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Planned to execute the new Oral OKN-007 clinical trial with modified study plan soon. This Study not proceeding and sites never opened.
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation cohort: 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID). Expansion cohort: MTD defined in the dose escalation study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oblato, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649464
- Sponsor's protocol ID
- OKN-007-OL-RMG-201
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2018
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/2 Open-label Study Investigating the Tolerability, Safety, Pharmacokinetic Properties and Efficacy of Oral OKN-007 in Participants With Recurrent High-grade Glioma
- ClinicalTrials.gov ID
- NCT03649464
- Acronym / sponsor ID
- OKN-007-OL-RMG-201
- Conditions
- Glioblastoma, Astrocytoma, Oligodendroglioma
- Keywords
- recurrent high-grade glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Planned to execute the new Oral OKN-007 clinical trial with modified study plan soon. This Study not proceeding and sites never opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oblato, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Aug 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.
The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.
Detailed description
Dose escalation/PK study (Phase Ib) will follow a traditional 3+3 design with evaluable participants enrolled at each dose level: Cohort 1 (1000mg, BID), Cohort 2, (1000mg, TID), and Cohort 3 (1500 mg, TID). The food-effect study will be one-week add-on study at the beginning of the dose escalation/PK study. Dose expansion study (Phase 2) will proceed to treat at the maximum tolerated dose (MTD) up to 2 years or until tumor progression, unacceptable toxicity, death or participants withdrawal. Participant may continue receiving treatment beyond 2 years at the discretion of investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation cohort: 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID). Expansion cohort: MTD defined in the dose escalation study.
| Arm | Type | Receives |
|---|---|---|
| OKN-007 | Experimental | Drug: OKN-007Oral OKN-007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Confirmed histopathology of recurrent gliomas that were originally diagnosed as, Glioblastoma (WHO Grade IV), Astrocytoma (WHO Grade III), or Oligodendroglioma (WHO Grade III). Participants with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be glioblastoma.
- Unequivocal radiographic evidence of tumor progression by MRI as per the RANO criteria within 14 days prior to registration.
- At least one measureable lesion per RANO.
- Prior radiotherapy
- Prior Temozolomide treatment, unless contraindications or intolerance.
Key exclusion criteria (8 listed)
- Second primary malignancy expected to require treatment within a 6 month period (except adequately treated basal cell carcinoma of the skin). Participants 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 participants and his/her ability to complete the study.
- with abnormal sodium, potassium, or creatinine levels ≥ grade 2.
- with PT/PTT or INR above the upper limit of normal, unless treated with anticoagulants (e.g. warfarin). In such cases coagulation parameters (INR) should be monitored weekly for the first six weeks of the study.
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-007Also: Anti-Cancer AgentDose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID). Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study. | Drug | OKN-007 |
Primary outcome
Number of Participants with DLTs (Dose Limiting Toxicities) and AEs (Adverse Events)
Time frame: 28 days
It will be summarized by dose cohort and by overall safety evaluable population using CTCAE v5.0 for Phase Ib dose escalation and Phase 2 dose expansion cohort.
Number of Participants with Best Overall Response Rate in the brain
Time frame: 24 months
The rate of participants with complete response of partial response using Response Assessment in Neuro-Oncology Criteria (RANO) will be summarized for Phase 2 dose expansion cohort.
7 secondary outcomes
Proportion of Participants as Assessed by 6-month Progression-Free Survival (PFS)
Time frame: 6 months
Proportion of Participants as Assessed by Overall Survival (OS)
Time frame: 24 months
The Cmax of OKN-007 in plasma
Time frame: Day 1 and Day 14
The Tmax (time to maximum concentration) of OKN-007 in plasma
Time frame: Day 1 and Day 14
AUC (area under the time curve) of OKN-007 in plasma
Time frame: Day 1 and Day 14
Plasma concentration of OKN-007
Time frame: Before the first dose on Day 8 and before the first dose of Day 29 in the morning
OKN-007 plasma levels over time for food-effect study
Time frame: Day 7 and Day 4 before the beginning of the dose escalation/PK study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OKN-007 in people with Glioblastoma and Astrocytoma, run by Oblato, Inc..
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 8 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: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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 Participants with DLTs (Dose Limiting Toxicities) and AEs (Adverse Events) (time frame: 28 days). 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?
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 7 Oct 2022.