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
NCT ID: NCT03776071
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2020-12-16
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
Radiotherapy (RT) plus temozolomide (TMZ) and enzastaurin (ENZ) (Concurrent Phase) followed by enzastaurin alone (Single-Agent Phase), then temozolomide and enzastaurin (Adjuvant Phase)
Enzastaurin Hydrochloride
mg
Temozolomide
mg/m\^2
Radiotherapy
Gy
RT plus TMZ and placebo; placebo; TMZ and placebo
Radiotherapy (RT) plus temozolomide (TMZ) and placebo followed placebo then by temozolomide and placebo
Placebo
mg
Temozolomide
mg/m\^2
Radiotherapy
Gy
Interventions
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Enzastaurin Hydrochloride
mg
Placebo
mg
Temozolomide
mg/m\^2
Radiotherapy
Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years with life expectancy \> 12 weeks
3. Histologically proven, newly diagnosed supratentorial glioblastoma (IDH mutant is excluded) based on the WHO classification (2016) which includes gliosarcoma (GS); prior diagnosis of lower grade astrocytoma that has been upgraded to histologically confirmed glioblastoma is eligible if chemotherapy and radiation therapy treatment-naïve
4. Randomization must occur within approximately 6 weeks after resection (patients undergoing biopsy only are excluded from the study)
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. Availability of tumor tissue representative of glioblastoma from surgery, and MGMT promoter methylation status is determined prior to study randomization
8. Karnofsky performance status (KPS) ≥ 70 (Appendix 1)
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
1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
2. Platelet count ≥ 100 x 109/L;
3. Hemoglobin ≥ 10 g/dL (eligibility level for hemoglobin may be met by transfusion) Renal
4. 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 (eg, Cockcroft-Gault or MDRD method).
Hepatic
5. Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome;
6. Aspartate and Alanine transaminase (AST/SGOT and ALT/SGPT) ≤ 2.5 x ULN;
7. Alkaline phosphatase (ALP) ≤ 2.5 x ULN
12. Negative serum pregnancy test (for females of childbearing potential) within 7 days prior to the first study treatment
13. Male and female patients of reproductive potential must agree to use an effective method of contraception (eg, 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 patients in regard to the last dose of temozolomide (TMZ), whichever is later
* Men are considered of reproductive potential unless they have undergone a vasectomy and confirmed sterile by a post-vasectomy semen analysis
* Male patients must agree not to donate their semen during treatment with temozolomide and for at least 6 months after their last dose of temozolomide
* 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
14. Willing and able to comply with the protocol
Exclusion Criteria
1. Unable to swallow tablets or capsules
2. Pregnant or breastfeeding
3. Prior chemotherapy (including carmustine-containing wafers (Gliadel®), immunotherapy (including vaccine therapy), or investigational products for GBM or GS (previous 5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) administered prior to surgery to aid in optimal surgical resection is permitted)
4. Glioblastoma IDH mutant
5. Prior radiation therapy to the brain
6. Unable to discontinue use of enzyme-inducing anti-epileptic drugs (EIAEDs), see Section 5.1.2.4.1; if previously taking EIAEDs, must have been discontinued ≥ 2 weeks prior to randomization
7. Use of a strong inducer or moderate or strong inhibitor of CYP3A4 (Appendix 2) within 7 days prior to randomization or expected requirement for use on study therapy
8. Use of warfarin that cannot be stopped prior to the study.
9. Use of any medication that can prolong the QT/QTc interval (Appendix 3) within 7 days prior to start of study therapy, or plan to use such a medication during the study
10. Active bacterial, fungal or viral infection requiring systemic treatment
11. Personal or family history of abnormal long QT interval, QTc interval \> 450 msec (males) or \> 470 msec (females) as read on the printout of the electrocardiogram (ECG) at screening (recommended that QTc be calculated using Fridericia's correction formula, QTcF: see Section 7.3.2.2), or a history of unexplained syncope
12. Unstable angina; myocardial infarction or coronary artery bypass graft/percutaneous stent placement within 6 months of starting study treatment, congestive heart failure requiring treatment (New York Heart Association \[NYHA\] Grade ≥2)
13. History of significant cardiac arrhythmia (ventricular tachycardia or fibrillation, Torsades de Pointe) or second- or third-degree A-V block, symptomatic bradycardia (unless controlled with a pacemaker)
14. Persistent electrolyte abnormalities such as hypokalemia or hypomagnesemia that do not respond to treatment
15. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
16. Evidence of chronic hepatitis C infection as indicated by antibody to hepatitis C virus (HCV) with positive HCV ribonucleic acid (RNA)
17. Evidence of active or chronic hepatitis B infection as indicated by either:
hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive with hepatitis B virus-deoxyribonucleic acid (HBV-DNA) positive (any detectable amount is considered positive)
18. Any contraindication to temozolomide listed in the local product label
19. Another malignancy except adequately treated non-melanoma skin cancer; patients who have had another primary malignancy in the past, but have been disease-free for more than 5 years, and patients who have had a localized malignancy treated with curative intent and disease free for more than 2 years are eligible
20. Participation in other studies involving investigational product(s) within 30 days prior to randomization
21. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for participation in this study
18 Years
ALL
No
Sponsors
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Denovo Biopharma LLC
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States
The University of Southern California
Pasadena, California, United States
University of California San Francisco Helen Diller Family Comprehensive CA Ctr
San Francisco, California, United States
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, United States
Blue Sky Neurology
Englewood, Colorado, United States
Smilow Cancer Hospital - New Haven
New Haven, Connecticut, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Norton Cancer Institute - Multidisciplinary Clinic
Louisville, Kentucky, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
John Nasseff Neuroscience Institute
Minneapolis, Minnesota, United States
Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, United States
Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, United States
New York University Medical Oncology Associates
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York - Presbyterian - Weill Cornell Medical Center
New York, New York, United States
Messino Cancer Centers
Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
The Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI - Tennessee Oncology - Nashville - Centennial
Nashville, Tennessee, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
Austin Cancer Center - Park St. David's
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Lynn Cancer Institute
Houston, Texas, United States
University of Texas Health Science Center at Houston (UT Health)
Houston, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Abbotsford
Abbotsford, British Columbia, Canada
British Columbia Cancer Agency - Victoria
Victoria, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada
First Affiliated Hospital of USTC - Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Tongji Hospital
Wuhan, Hubei, China
Shengjing Hospital - Nanhu Campus
Shenyang, Liaoning, China
Tangdu Hospital
Xi'an, Shaanxi, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Xianshuigu, Tianjin Municipality, China
Countries
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Other Identifiers
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DB102-01
Identifier Type: -
Identifier Source: org_study_id
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