Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
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.
- Drug: DS-1001bGeneric not assigned
|Ages eligible for Study||20 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Has histologically confirmed glioma with an IDH1-R132 mutation
- Has disease that has recurred or progressed following standard treatment including radiotherapy
- Has measurable lesion(s) as per RANO criteria
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Has significant symptoms of increased intracranial pressure
- Has another active neoplasm
- Has active infection requiring systemic treatment
- Has a history of severe cardiac disease
- Has had prior treatment with any inhibitor targeting mutant IDH1
- Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
- Is a pregnant or lactating female
- National Cancer Center HospitalrecruitingTokyo, Japan
18 January, 2017
01 January, 2018