At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 460 target
Drug / intervention
Temozolomide +4 moredrug
Likely dose
Not stated in record
Key inclusion· 13
- ✓Histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection
- ✓Age 18 years or older
- ✓No prior systemic or radiation therapy for glioblastoma
- ✓Ability to swallow pills
Key exclusion· 30
- ✕Infratentorial glioblastoma or gliosarcoma
- ✕Original diagnosis of lower grade glioma with subsequent progression to glioblastoma
- ✕Planned major surgery
- ✕Current investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
In Brief
A Phase 2 clinical trial evaluating Temozolomide, Neratinib, and 3 other interventions for Glioblastoma. Currently recruiting, targeting 460 participants across 12 sites.
Detailed Summary
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited States
Timeline
Phase 2Recruiting
201720182019202020212022202320242025202620272028
First PostedNov 2016
Enrollment StartFeb 2017
TodayJul 2026
Primary CompletionFeb 2028
Study CompletionApr 2028
First PostedNov 30, 2016
Enrollment StartFeb 9, 2017
Primary CompletionFeb 1, 2028
Study CompletionApr 30, 2028
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 9.6 years agoPrimary completion in 1.6 years
Interventions
Temozolomidedrug
Temzolomide capsules
Neratinibdrug
Neratinib tablets
QBS10072Sdrug
QBS10072S administered intravenously
Abemaciclibdrug
Abemaciclib tablets
CC-115drug
CC-115 tablets