Glioblastoma Clinical Trial
Official title:
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
| Verified date | November 2023 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Active, not recruiting |
| Enrollment | 194 |
| Est. completion date | May 15, 2026 |
| Est. primary completion date | May 12, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Local Institution - 503 | Aalborg | |
| Denmark | Local Institution - 501 | Copenhagen | |
| Denmark | Local Institution - 500 | Odense | |
| Italy | Local Institution - 202 | Milan | |
| Italy | Local Institution - 201 | Milano | |
| Italy | Local Institution - 204 | Padova | |
| Italy | Local Institution - 200 | Verona | |
| Netherlands | Local Institution - 405 | Amsterdam | |
| Netherlands | Local Institution - 408 | Leiden | Zuid-Holland |
| Netherlands | Local Institution - 400 | Rotterdam | |
| Netherlands | Local Institution - 401 | Utrecht | |
| Norway | Local Institution - 600 | Oslo | |
| Spain | Local Institution - 311 | A Coruna | |
| Spain | Local Institution - 302 | Barcelona | |
| Spain | Local Institution - 303 | Barcelona | |
| Spain | Local Institution - 306 | Barcelona | |
| Spain | Local Institution - 307 | Hospitalet de Llobregat, Barcelona | |
| Spain | Local Institution - 300 | Madrid | |
| Spain | Local Institution - 301 | Madrid | |
| Spain | Local Institution - 304 | Madrid | |
| Spain | Local Institution - 310 | Pamplona | |
| Spain | Local Institution - 309 | Sevilla | |
| Spain | Local Institution - 305 | Valencia | |
| Spain | Local Institution - 312 | Vigo | |
| Sweden | Local Institution - 702 | Goteborg | |
| Sweden | Local Institution - 701 | Lund | |
| Sweden | Local Institution - 700 | Solna | |
| Sweden | Local Institution - 703 | Uppsala | |
| United States | Local Institution - 800 | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Denmark, Italy, Netherlands, Norway, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 | Parts A and B | Up to 3 years | |
| Primary | Incidence of dose-limiting toxicities (DLTs) | Part A | Up to 3 years | |
| Primary | Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) | Part A | Up to 3 years | |
| Primary | MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) | Part A | Up to 3 years | |
| Primary | Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ | Part A | Up to 3 years | |
| Primary | RP2D of CC-90010 in combination with TMZ and RT | Part A | Up to 3 years | |
| Primary | Median Progression-free survival (PFS) in Arm A vs Arm B | Part B | Up to 12 months | |
| Primary | Hazard ratio for PFS in Arm A vs Arm B | Part B | Up to 12 months | |
| Secondary | 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 | |
| Secondary | 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 | Parts A and B | Up to 5 years | |
| Secondary | Duration of therapy (DoT) in Arm A vs Arm B | Part B | Up to 5 years | |
| Secondary | Response by Response Assessment in Neuro-Oncology (RANO) criteria | Parts A and B | Up to 5 years | |
| Secondary | Pharmacokinetics - Maximum observed plasma concentration (Cmax) | Parts A and B | Up to 2 years | |
| Secondary | Pharmacokinetics - Area under the plasma concentration time-curve (AUC) | Parts A and B | Up to 2 years | |
| Secondary | Pharmacokinetics - Time to maximum plasma concentration (Tmax) | Parts A and B | Up to 2 years |
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