WHO Grade II Glioma
Conditions
Keywords
DS-1001, IDH1, Glioma, IDH-mutant glioma, WHO grade II glioma, Low-grade glioma
Brief summary
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.
Interventions
DRUGDS-1001b
250 mg, twice daily, continuous oral administration
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification. * Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period. * Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy. * Has at least 1 measurable and non-enhancing lesion. * Has an interval of at least 90 days from the latest surgery. * Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
Exclusion criteria
* Has had a histopathological diagnosis of WHO grade III or IV glioma. * Has had a contrast enhancing lesion on brain MRI. * Has received a prior treatment with any mutant IDH1 inhibitor. * Has received other investigational products within 28 days before the start of the study drug treatment. * Has an active infection requiring systemic treatment. * Has multiple primary malignancies. * Has a history of clinically significant cardiac disease. * Is a pregnant or lactating woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) assessed by Independent Efficacy Review Committee | Up to 24 months |
| Number of participants with treatment-emergent adverse events (TEAEs) during the study | Up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate | Through the end of the study (up to approximately 6 years) |
| Percentage change in tumor volume | Through the end of the study (up to approximately 6 years) |
| Time to response | Through the end of the study (up to approximately 6 years) |
| Duration of response | Through the end of the study (up to approximately 6 years) |
| Time to treatment failure | Through the end of the study (up to approximately 6 years) |
| Progression-free survival | Through the end of the study (up to approximately 6 years) |
| Overall survival | Through the end of the study (up to approximately 6 years) |
| Area under the concentration curve (AUC) for DS-1001a | Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) |
| Maximum plasma concentration (Cmax) for DS-1001a | Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) |
| Time to maximum plasma concentration (Tmax) for DS-1001a | 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 | Through the end of the study (up to approximately 6 years) |
Countries
Japan
Contacts
STUDY_DIRECTORClinical Study Leader
Daiichi Sankyo
Outcome results
None listed