A Phase II study of DS-1001b in Patients with IDH1 mutated WHO grade II glioma
Phase 2
Completed
- Conditions
- glioma
- Registration Number
- jRCT2080225243
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 25
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 central laboratory testing.
- Has no prior anticancer (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 lesion and/or rapid growth of non-enhancing lesion.
- 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 multiple primary malignancies.
- Has an active infection requiring systemic treatment.
- Has a history of clinically significant cardiac disease.
- Is a pregnant or lactating woman
Study & Design
- Study Type
- Interventional
- Study Design
- Multicenter, Open-label, Single-arm, Phase II study
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
Location not specified
Japan