This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
250 mg, twice daily, continuous oral administration
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Saitama Medical University International Medical Center
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Time frame: Up to 24 months
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Time frame: Up to 24 months
Clinical benefit rate
Time frame: Through the end of the study (up to approximately 6 years)
Percentage change in tumor volume
Time frame: Through the end of the study (up to approximately 6 years)
Time to response
Time frame: Through the end of the study (up to approximately 6 years)
Duration of response
Time frame: Through the end of the study (up to approximately 6 years)
Time to treatment failure
Time frame: Through the end of the study (up to approximately 6 years)
Progression-free survival
Time frame: Through the end of the study (up to approximately 6 years)
Overall survival
Time frame: Through the end of the study (up to approximately 6 years)
Area under the concentration curve (AUC) for DS-1001a
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Maximum plasma concentration (Cmax) for DS-1001a
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Hidaka, Saitama, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
Kyoto University Hospital
Kyoto, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Kyorin University Hospital
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
...and 1 more locations
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) for DS-1001a
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time frame: Through the end of the study (up to approximately 6 years)