A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
NCT ID: NCT04324840
Last Updated: 2024-07-26
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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TERMINATED
PHASE1
184 participants
INTERVENTIONAL
2020-07-10
2024-07-09
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
NONE
Study Groups
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Part A
CC-90010
Specified dose on specified days
Temozolomide
Specified dose on specified days
Radiotherapy
Specified dose on specified days
Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
CC-90010
Specified dose on specified days
Temozolomide
Specified dose on specified days
Radiotherapy
Specified dose on specified days
Part B - Standard TMZ + RT
Control
Radiotherapy
Specified dose on specified days
Interventions
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CC-90010
Specified dose on specified days
Temozolomide
Specified dose on specified days
Radiotherapy
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
* Karnofsky performance status of ≥70
Exclusion Criteria
* Biopsy only of glioblastoma (GBM) at surgery, defined as \< 20% resection of enhancing tumor
* Any known metastatic extracranial or leptomeningeal disease
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 800
New York, New York, United States
Local Institution - 503
Aalborg, , Denmark
Local Institution - 501
Copenhagen, , Denmark
Local Institution - 500
Odense, , Denmark
Local Institution - 202
Milan, , Italy
Local Institution - 201
Milan, , Italy
Local Institution - 204
Padua, , Italy
Local Institution - 200
Verona, , Italy
Local Institution - 408
Leiden, South Holland, Netherlands
Local Institution - 405
Amsterdam, , Netherlands
Local Institution - 400
Rotterdam, , Netherlands
Local Institution - 401
Utrecht, , Netherlands
Local Institution - 600
Oslo, , Norway
Local Institution - 311
A Coruña, , Spain
Local Institution - 306
Barcelona, , Spain
Local Institution - 302
Barcelona, , Spain
Local Institution - 303
Barcelona, , Spain
Local Institution - 307
Hospitalet de Llobregat, Barcelona, , Spain
Local Institution - 304
Madrid, , Spain
Local Institution - 301
Madrid, , Spain
Local Institution - 300
Madrid, , Spain
Local Institution - 310
Pamplona, , Spain
Local Institution - 309
Seville, , Spain
Local Institution - 305
Valencia, , Spain
Local Institution - 312
Vigo, , Spain
Local Institution - 702
Gothenburg, , Sweden
Local Institution - 701
Lund, , Sweden
Local Institution - 700
Solna, , Sweden
Local Institution - 703
Uppsala, , Sweden
Countries
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References
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Moreno V, Manuel Sepulveda J, Reardon DA, Perez-Nunez A, Gonzalez Leon P, Hanna B, Filvaroff E, Aronchik I, Chang H, Amoroso B, Zuraek M, Sanchez-Perez T, Mendez C, Stephens D, Nikolova Z, Vogelbaum MA. Trotabresib, an oral potent bromodomain and extraterminal inhibitor, in patients with high-grade gliomas: A phase I, "window-of-opportunity" study. Neuro Oncol. 2023 Jun 2;25(6):1113-1122. doi: 10.1093/neuonc/noac263.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1248-0496
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004122-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-90010-GBM-002
Identifier Type: -
Identifier Source: org_study_id
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