Glioblastoma
Conditions
Keywords
CC-90010, Temozolomide, Glioblastoma, NEWLY DIAGNOSED, Radiation therapy, Safety, Tolerability, MTD and RP2D
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 diagnosed WHO Grade IV glioblastoma (ndGBM).
Interventions
DRUGCC-90010
Specified dose on specified days
DRUGTemozolomide
Specified dose on specified days
RADIATIONRadiotherapy
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D of CC-90010 in combination with TMZ and RT | Up to 3 years | Part A |
| Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 3 years | Parts A and B |
| Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 | Up to 3 years | Parts A and B |
| Incidence of dose-limiting toxicities (DLTs) | Up to 3 years | Part A |
| Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) | Up to 3 years | Part A |
| MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) | Up to 3 years | Part A |
| Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ | Up to 3 years | Part A |
| Hazard ratio for PFS in Arm A vs Arm B | Up to 12 months | Part B |
| Median Progression-free survival (PFS) in Arm A vs Arm B | Up to 12 months | Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Area under the plasma concentration time-curve (AUC) | Up to 2 years | Parts A and B |
| Pharmacokinetics - Time to maximum plasma concentration (Tmax) | Up to 2 years | Parts A and B |
| Response by Response Assessment in Neuro-Oncology (RANO) criteria | Up to 5 years | Parts A and B |
| Pharmacokinetics - Maximum observed plasma concentration (Cmax) | Up to 2 years | Parts A and B |
| 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 | Up to 5 years | Parts A and B |
| 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 | Up to 5 years | Parts A and B |
| Duration of therapy (DoT) in Arm A vs Arm B | Up to 5 years | Part B |
Countries
Denmark, Italy, Netherlands, Norway, Spain, Sweden, United States
Outcome results
None listed