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A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas (NCT03030066)

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-1001b
    Generic not assigned
    • Investigational
Ages eligible for Study
20 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • 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
Exclusion Criteria:
  • 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

1 locations

Japan (1)
  • National Cancer Center Hospital
    recruiting
    Tokyo, Japan
Status:
recruiting
Type:
Interventional
Phase:
-
Start:
18 January, 2017
Updated:
09 February, 2017
Participants:
60
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