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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.
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Full eligibility criteria for NCT03030066
Ages eligible for Study
20 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
All locations for NCT03030066
National Cancer Center Hospital
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Tris trial is registered with FDA with number:
. The sponsor of the trial is
Daiichi Sankyo Co., Ltd.
and it is
looking for 60 volunteers
for the current phase.
Official trial title:
A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas
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