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Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients (OKN-007)

Primary Purpose

Recurrent Malignant Glioma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OKN-007

About this trial

This is an interventional treatment trial for Recurrent Malignant Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%
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

Exclusion Criteria:

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

Sites / Locations

Oklahoma University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

All participants enrolled in this study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PK level in participants

To determine drug levels of OKN-007 in blood.

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.

Full Information

NCT ID

NCT01672463

First Posted

August 21, 2012

Last Updated

March 28, 2023

Sponsor

Oblato, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01672463

Brief Title

Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

Acronym

OKN-007

Official Title

Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2012 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oblato, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Malignant Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All patients

Arm Type

Experimental

Arm Description

All participants enrolled in this study

Intervention Type

Drug

Intervention Name(s)

OKN-007

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Adverse events per patient

Description

The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

PK level in participants

Description

To determine drug levels of OKN-007 in blood.

Time Frame

24 months

Title

6 month progression-free survival

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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% 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Battiste, MD, PhD

Organizational Affiliation

• Oklahoma University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oklahoma University

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

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