Glioma
Conditions
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must have histologically confirmed glioma with an IDH1-R132 mutation. 2) Subjects must have disease that has recurred or progressed following standard treatment including radiation therapy. 3) Subjects must have measurable lesion(s) as per RANO criteria. 4) Subjects must have ECOG PS of 0 to 2.
Exclusion criteria
Exclusion criteria: 1) Subjects with significant symptoms of increased intracranial pressure. 2) Subjects who have active another neoplasm. 3) Subjects with active infection requiring systemic treatment. 4) Subjects with a history of severe cardiac disease 5) Subjects who have received prior treatment with any therapy targeting mutant IDH1. 6) Subjects who have received other investigational drug treatment within 3 weeks prior to the first dose of study treatment. 7) Female subjects who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of DS-1001b | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics 1) To assess the safety and tolerability of DS-1001b 2) To characterize the pharmacokinetic (PK) profile of DS-1001b 3) To characterize the pharmacodynamic (PDy) effect of DS-1001b on 2-HG levels 4) To assess the preliminary anti-tumor activity of DS-1001b Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group. | — |
Countries
Japan
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed