A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
- Registration Number
- NCT04458272
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DS-1001b DS-1001b -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) during the study Up to 24 months Overall response rate (ORR) assessed by Independent Efficacy Review Committee Up to 24 months
- Secondary Outcome Measures
Name Time Method Overall survival Through the end of the study (up to approximately 6 years) Time to maximum plasma concentration (Tmax) 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) 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) 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) Area under the concentration curve (AUC) for DS-1001a Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) 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)
Trial Locations
- Locations (11)
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kyorin University Hospital
🇯🇵Tokyo, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan