Diffuse glioma confirmed with IDH1 or IDH2 mutation who have undergone surgery as only treatment
Conditions
Interventions
-Vorasidenib
Administered orally with 20 mg or 40 mg of vorasidenib per day.
Sponsors
Shimada Toshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Be at least 12 years of age -Be diagnosed with a predominantly non-enhancing oligodendroglioma or astrocytoma as per the World Health Organization (WHO) 2021 criteria -Have IDH1 or IDH2 mutations confirmed by tissue-based diagnosis as per locally validated biomolecular profiling methods in clinical routine practice -Have had one or more prior surgical interventions for glioma -Have adequate bone marrow, hepatic, and renal functions -Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician -Be able to understand and willing to sign informed consent/assent as determined by local requirements
Exclusion criteria
Exclusion criteria: -Are participating in another investigational or interventional clinical study -Have had any prior anticancer therapy other than surgery for treatment of glioma including systemic chemotherapy, radiotherapy, IDH inhibitors, and other anticancer therapies (investigational agents) -Are pregnant or breast feeding -Are men or women not using highly effective forms of contraception during the trial -Have Grade 4 astrocytoma per WHO 2021 criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, severity, and type of AEs. | — |
Contacts
Public ContactToshihiko Shimada
PPD-SNBL K.K.
Outcome results
None listed