CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 124 target
Drug / intervention
Vismodegib +3 moredrug
Likely dose
Not stated in record
Key inclusion· 17
  • ✓Histologically proven intracranial meningioma documented by central pathology review
  • ✓Presence of one of the following mutations/alterations: SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations; CDKN2A copy number loss; or CDK4, CDK6, CCND1, CCND2, CCND3, CCNE1 copy number gain documented by central laboratory
  • ✓Progressive or residual measurable disease meeting defined criteria
  • ✓Measurable bidimensionally measurable lesion on MRI/CT with minimum diameter of 10 mm in both dimensions
Key exclusion· 22
  • ✕Metastatic meningiomas (extracranial meningiomas outside CNS) are not allowed
  • ✕History of allergic reactions to compounds of similar or biologic composition to assigned study drug
  • ✕Known active hepatitis B or C
  • ✕Current Child Pugh class B or C liver disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02523014
NCT02523014Phase 2RecruitingOn Track
Long Recruiting
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Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 14, 2015·Updated Jun 2, 2026

In Brief

A Phase 2 clinical trial evaluating Vismodegib, FAK Inhibitor GSK2256098, and 2 other interventions for Intracranial Meningioma and 2 related conditions. Currently recruiting, targeting 124 participants across 780 sites.

Detailed Summary

This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), GlaxoSmithKline, Genentech, Inc., Brain Science Foundation

Timeline

Phase 2Recruiting
2016201720182019202020212022202320242025202620272028
First PostedAug 14, 2015
Enrollment StartSep 28, 2015
Primary CompletionJan 1, 2027
Study CompletionJan 1, 2028
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 10.9 years agoPrimary completion in 6 months

Interventions

Vismodegibdrug

Given PO

FAK Inhibitor GSK2256098drug

Given PO

Capivasertibdrug

Given PO

Abemaciclibdrug

Given PO