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

  • STATUS
    Recruiting
  • participants needed
    56
  • sponsor
    Oblato, Inc.
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Updated on 19 February 2024
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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.

Details
Condition Recurrent Malignant Glioma, Brain Glioblastoma
Age 18-100 years
Treatment OKN-007, Temozolomide (TMZ)
Clinical Study IdentifierNCT04388475
SponsorOblato, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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)
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
Unequivocal radiographic evidence of tumor progression by MRI
At least one measurable lesion per RANO criteria within 21 days prior to registration
No more than one prior line of therapy for glioblastoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Full recovery ( grade 1) from the toxic effects
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
Patients must be 18 years of age

Exclusion Criteria

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