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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1248-0496 | Other Identifier | WHO | |
| 2019-004122-25 | EudraCT Number |
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Business objectives have changed
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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 diagnosed WHO Grade IV glioblastoma (ndGBM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) | Experimental |
| |
| Part B - Standard TMZ + RT | Other | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-90010 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Parts A and B | Up to 3 years |
| Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 | Parts A and B | Up to 3 years |
| Incidence of dose-limiting toxicities (DLTs) | Part A | Up to 3 years |
| Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) | Part A | Up to 3 years |
| MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) | Part A | Up to 3 years |
| Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ | Part A | Up to 3 years |
| RP2D of CC-90010 in combination with TMZ and RT | Part A | Up to 3 years |
| Median Progression-free survival (PFS) in Arm A vs Arm B | Part B | Up to 12 months |
| Hazard ratio for PFS in Arm A vs Arm B |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause | Parts A and B | Up to 5 years |
| Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 800 | New York | New York | 10075 | United States | ||
| Local Institution - 503 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36455228 | Derived | 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
See Plan Description
See Plan Description
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| Temozolomide | Drug | Specified dose on specified days |
|
| Radiotherapy | Radiation | Specified dose on specified days |
|
Part B |
| Up to 12 months |
Parts A and B |
| Up to 5 years |
| Duration of therapy (DoT) in Arm A vs Arm B | Part B | Up to 5 years |
| Response by Response Assessment in Neuro-Oncology (RANO) criteria | Parts A and B | Up to 5 years |
| Pharmacokinetics - Maximum observed plasma concentration (Cmax) | Parts A and B | Up to 2 years |
| Pharmacokinetics - Area under the plasma concentration time-curve (AUC) | Parts A and B | Up to 2 years |
| Pharmacokinetics - Time to maximum plasma concentration (Tmax) | Parts A and B | Up to 2 years |
| Aalborg |
| 9100 |
| Denmark |
| Local Institution - 501 | Copenhagen | 2100 | Denmark |
| Local Institution - 500 | Odense | 5000 | Denmark |
| Local Institution - 202 | Milan | 20089 | Italy |
| Local Institution - 201 | Milan | 20132 | Italy |
| Local Institution - 204 | Padova | 35128 | Italy |
| Local Institution - 200 | Verona | 37126 | Italy |
| Local Institution - 408 | Leiden | South Holland | 2333 ZA | Netherlands |
| Local Institution - 405 | Amsterdam | 1066 CX | Netherlands |
| Local Institution - 400 | Rotterdam | 3015 GD | Netherlands |
| Local Institution - 401 | Utrecht | 3584 CX | Netherlands |
| Local Institution - 600 | Oslo | 0424 | Norway |
| Local Institution - 311 | A Coruña | 15006 | Spain |
| Local Institution - 306 | Barcelona | 08003 | Spain |
| Local Institution - 302 | Barcelona | 08035 | Spain |
| Local Institution - 303 | Barcelona | 08036 | Spain |
| Local Institution - 307 | Hospitalet de Llobregat, Barcelona | 08907 | Spain |
| Local Institution - 304 | Madrid | 28034 | Spain |
| Local Institution - 301 | Madrid | 28040 | Spain |
| Local Institution - 300 | Madrid | 28041 | Spain |
| Local Institution - 310 | Pamplona | 31008 | Spain |
| Local Institution - 309 | Seville | 41013 | Spain |
| Local Institution - 305 | Valencia | 46026 | Spain |
| Local Institution - 312 | Vigo | 36312 | Spain |
| Local Institution - 702 | Gothenburg | 413 45 | Sweden |
| Local Institution - 701 | Lund | 222 41 | Sweden |
| Local Institution - 700 | Solna | 171 64 | Sweden |
| Local Institution - 703 | Uppsala | 75185 | Sweden |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| C537356 | Metatropic dwarfism |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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