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Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT04388475
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Oblato, Inc.

Brief Summary:
This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). 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. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.

Condition or disease Intervention/treatment Phase
Recurrent Malignant Glioma Brain Glioblastoma Drug: OKN-007 Drug: Temozolomide (TMZ) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : May 25, 2022
Estimated Study Completion Date : October 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients
All patients enrolled in this study
Drug: OKN-007
Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.

Drug: Temozolomide (TMZ)
Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.




Primary Outcome Measures :
  1. Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide [ Time Frame: Through study completion up to 24 months ]
    Evaluate incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

  2. Number of subjects with decreased neurological function [ Time Frame: Change from baseline at Day 1 of each 28 day cycle ]
    Neurologic function assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale. The NANO Scale evaluates 9 major domains of neurologic function, with each domain being scored on a range from 0 (no deficits) to 2 or 3 (maximum deficits).

  3. Number of subjects with decreased performance [ Time Frame: Change from baseline at Day 1 of each 28 day cycle ]
    Number of participants with decreased performance assessed by Eastern Oncology Cooperative Group (ECOG) scale. Minimum 0 (normal function) and maximum 4 (maximum disability).

  4. Overall Survival (OS) rate [ Time Frame: 6 months ]
    Proportion of subjects who are alive after six months of starting treatment. OS is defined as the time from first treatment dose until date of death due to any cause.


Secondary Outcome Measures :
  1. Radiographic response rate [ Time Frame: 24 months ]
    To determine the objective response rate to study therapy using Radiographic Assessment in Neuro-Oncology (RANO) criteria.

  2. Progression Free Survival (PFS) rate [ Time Frame: 6 months ]
    Proportion of subjects who are alive and progression free after six months of starting treatment. PFS is defined as the time from first treatment dose until objective tumor progression on the RANO criteria or death.

  3. Cmax of OKN-007 in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  4. AUC of OKN-007 in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  5. Tmax of OKN-007 in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  6. Cmax of Temozolomide in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

  7. AUC of Temozolomide in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

  8. Tmax of Temozolomide in blood plasma [ Time Frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle) ]
    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed histopathology of recurrent GBM (WHO Grade IV), following primary treatment with TMZ and radiotherapy (minimum of 50 Gy) and at least two cycles of maintenance TMZ (5 days of a 28 day cycle).
  2. Patients must have tumor tissue samples available from the GBM surgery or open biopsy for O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status analysis or must have medical record available to document MGMT status.
  3. Unequivocal radiographic evidence of tumor progression by MRI
  4. At least one measurable lesion per RANO criteria within 21 days prior to registration.
  5. No more than one prior line of therapy for glioblastoma.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  7. Full recovery (≤ grade 1) from the toxic effects.
  8. Adequate renal, liver and bone marrow function:

    • Hemoglobin >9.0 g/dL
    • Leukocytes >3,000/mcL
    • Absolute neutrophil count >1,500/mcL
    • Platelets >100,000/mcL
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    • AST (SGOT) / ALT (SGPT) ≤2.5 × ULN
    • Creatinine clearance ≥ 60 mL/min

10. Patients must be ≥18 years of age

Exclusion Criteria:

  1. Early discontinuation of TMZ in first line due to treatment related Adverse events (AEs).
  2. Second primary malignancy expected to require treatment within a 6 month period (except adequately treated basal cell carcinoma of the skin).
  3. 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.
  4. Serious concomitant systemic disorders
  5. Patients with abnormal sodium, potassium, or creatinine levels ≥ grade 2.
  6. Patients with prothrombin time/partial thromboplastin time (PT/PTT) or International normalized ratio (INR) above the ULN.
  7. Inability to comply with protocol or study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388475


Contacts
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Contact: Alex E. KIM Project Manager 609-734-4329 Alex@oblatoinc.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Thiru Pillay    205-934-1432    tpillay@uabmc.edu   
Principal Investigator: Louis Nabors, MD         
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Katy Gilbert       Kathryn.Gilbert@DignityHealth.org   
Principal Investigator: Ekokobe Fonkem, DO         
United States, California
Providence Saint John's Health Center - John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Ashley Archer    310-582-7460    Ashley.Archer@providence.org   
Principal Investigator: Santosh Kesari, M.D., Ph.D.         
Sub-Investigator: Naveed Wagle, M.D.         
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Judith Stucky       Judith.Stucky@HCAhealthcare.com   
Principal Investigator: Michael Pearlman, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stephanie Mintoff       Smintof1@hfhs.org   
Principal Investigator: Tobias Walbert, M.D., Ph.D.         
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashley Carroll       arcarrol@wakehealth.edu   
Principal Investigator: Glenn Lesser, MD         
United States, Ohio
The University of Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact: Stephanie Smiddy       stephanie.smiddy@utoledo.edu   
Principal Investigator: Ronald Skeel, MD         
United States, Oklahoma
The University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Hee Sun Kim-Suh       HeeSun-Kim@ouhsc.edu   
Principal Investigator: James Battiste, MD.,PhD         
Sponsors and Collaborators
Oblato, Inc.
Investigators
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Study Director: Shinwook Kang Oblato, Inc.
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Responsible Party: Oblato, Inc.
ClinicalTrials.gov Identifier: NCT04388475    
Other Study ID Numbers: OKN-007-IV-RMG-201
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents