Clinical trial · Interventional
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
NCT04324840CI-TRIAL-00079162terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-90010 | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part A
- interventionNames
- Drug: CC-90010
- Drug: Temozolomide
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
- interventionNames
- Drug: CC-90010
- Drug: Temozolomide
- Radiation: Radiotherapy
- type
- OTHER
- label
- Part B - Standard TMZ + RT
- description
- Control
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDMoreno 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. PMID 36455228