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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Malignant Glioma
• Intervention / Treatment: Drug: OKN-007

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
2. Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
3. Prior radiotherapy
4. Prior Temozolomide treatment
5. 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)
6. Karnofsky performance status greater than or equal to 60%
7. 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

8. 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
9. Patients must be >_18 years of age

Exclusion Criteria:

1. 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
2. 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
3. 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
4. Patients with moderate or severe renal impairment (calculated creatinine clearance of < 60 mL/min)
5. Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
6. Patients with PT/PTT above the upper limit of normal
7. Screening ECG abnormality documented by the investigator as medically significant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; All participants enrolled in this study	Drug: OKN-007; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK level in participants	To determine drug levels of OKN-007 in blood.	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.	24 months

Collaborators and Investigators

• Sponsor: Oblato, Inc.
• Investigators: Principal Investigator: James Battiste, MD, PhD, • Oklahoma University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): January 31, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Recurrence; Glioma
• Other Study ID Numbers: HCI57337