Status:
TERMINATED
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
Lead Sponsor:
Celgene
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagn...
Eligibility Criteria
Inclusion
- Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
- O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
- Karnofsky performance status of ≥70
Exclusion
- Indeterminate MGMT promoter methylation status
- Biopsy only of glioblastoma (GBM) at surgery, defined as \< 20% resection of enhancing tumor
- Any known metastatic extracranial or leptomeningeal disease
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04324840
Start Date
July 10 2020
End Date
July 9 2024
Last Update
July 26 2024
Active Locations (29)
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1
Local Institution - 800
New York, New York, United States, 10075
2
Local Institution - 503
Aalborg, Denmark, 9100
3
Local Institution - 501
Copenhagen, Denmark, 2100
4
Local Institution - 500
Odense, Denmark, 5000