Status:
COMPLETED
A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Celgene
Canadian Cancer Trials Group
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis rema...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
- Tumor resection (gross total or partial), or biopsy only
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor block or 24 unstained slides for o6-methylguanine-DNA-methyltransferase (MGMT) analysis
- Patient must be eligible for standard TMZ/RT + TMZ
- Karnofsky performance score (KPS) ≥ 70
- Recovered from effects of surgery, postoperative infection and other complications of surgery (if any)
- The patient is at least 18 years of age on day of signing informed consent
- Stable or decreasing dose of steroids for at least 1 week prior to inclusion
- The patient has a life expectancy of at least 3 months
- Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy)
- The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function within the following ranges:
- white blood cell count (WBC) ≥ 3×10\*9/L
- absolute neutrophil count (ANC) ≥ 1.5×10\*9/L
- Platelet count of ≥ 100×10\*9/L independent of transfusion
- Hemoglobin ≥ 10 g/dl
- Total Bilirubin ≤ 1.5 upper limit of normal (ULN)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5 × ULN
- Serum creatinine \< 1.5 x ULN or creatinine clearance (CrCl) \> 30 mL/min(using the Cockcroft-Gault formula)
- Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment.
- Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1 percent per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 6 months after receiving the last dose of study treatment.
- Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
- Ability to take oral medication
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Before patient registration/randomization, written informed consent must be given according to International Council for Harmonisation (ICH) / Good clinical practice (GCP), and national/local regulations.
Exclusion
Key Trial Info
Start Date :
July 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
749 Patients enrolled
Trial Details
Trial ID
NCT03345095
Start Date
July 26 2018
End Date
June 30 2023
Last Update
July 1 2025
Active Locations (82)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
University of California at Irvine
Orange, California, United States, 92868
3
University of California
San Francisco, California, United States, 94143-0372
4
John Wayne Cancer Institute
Santa Monica, California, United States, 90404