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A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1

Status
Active
Cancer Type
Brain & Spinal Cord Tumor
Brain Tumor
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03776071
Protocol IDs
DB102-01 (primary)
NCI-2020-13730
Study Sponsor
Denovo Biopharma LLC

Summary

This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center
Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all
eligibility criteria will be enrolled.

Eligibility

  1. Signed informed consent
  2. Age = 18 years with life expectancy > 12 weeks
  3. Histologically proven, newly diagnosed supratentorial glioblastoma based on the World Health Organization (WHO) classification (2016); prior diagnosis of lower grade astrocytoma that has been upgraded to histologically confirmed glioblastoma is eligible if chemotherapy and radiotherapy treatment-naïve
  4. Randomization must occur within 6 weeks of resection (subjects undergoing biopsy only are excluded)
  5. Craniotomy site must be adequately healed, free of drainage or cellulitis and the underlying cranioplasty must appear intact prior to start of study treatment
  6. DGM1 biomarker status (positive or negative) is available prior to randomization.
  7. Available and willing to submit sufficient and of adequate quality tumor tissue representative of glioblastoma to perform MGMT promoter methylation status testing
  8. Karnofsky performance status (KPS) = 70
  9. Stable or decreasing corticosteroids within 5 days prior to study treatment start
  10. Willing to forego the use of Tumor Treating Fields therapy (Optune®)
  11. Adequate organ function within 14 days prior to randomization: Bone marrow
  12. Absolute neutrophil count (ANC) = 1.5 x 10?/L;
  13. Platelets count = 100 x 10?/L;
  14. Hemoglobin = 10 g/dL (eligibility level for hemoglobin may be met by transfusion) Renal a. Serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 60 mL/min as calculated using an appropriately validated prediction equation for the estimation of eGFR (e.g. Cockcroft-Gault or MDRD method) Hepatic
  15. Total serum bilirubin = 1.5 x ULN unless the patient has documented Gilbert syndrome;
  16. Aspartate and alanine transaminase (AST/SGOT and ALT/SGPT) = 2.5 x ULN
  17. Alkaline phosphatase (ALP) = 2.5 x ULN
  18. Negative serum pregnancy test (for females of childbearing potential) within 7 days prior to the first study treatment
  19. Male and female subjects of reproductive potential must agree to use an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method) throughout the study and for at least 3 months after the last dose of study treatment, or 6 months for female subjects in regard to the last dose of temozolimide (TMZ), whichever is later
  20. Men are considered of reproductive potential unless they have undergone a vasectomy and confirmed sterile by a post-vasectomy semen analysis
  21. Women are considered of reproductive potential unless they have undergone hysterectomy and/or surgical sterilization (at least 6 weeks following a bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusive procedure that has been confirmed in accordance with the device's label), have medically confirmed ovarian failure, or achieved postmenopausal status (defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women
  22. Willing and able to comply with protocol
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