This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Generic not assigned
National Cancer Center Hospital
Tokyo, Japan
Percentage of participants with dose limiting toxicities
Time frame: 21 days
Percentage of participants experiencing an adverse event (AE)
AEs temporally associated with DS-1001b treatment
Time frame: up to 36 months
Area under the concentration curve (AUC) for DS-1001b
Time frame: up to 36 months
Maximum plasma concentration (Cmax) for DS-1001b
Time frame: up to 36 months
Time to maximum plasma concentration (Tmax) for DS-1001b
Time frame: up to 36 months
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time frame: Baseline, up to 36 months
Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
Time frame: up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.