Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas
Washington University School of Medicine
Summary
This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant glioma undergoing tumor resection. Tissue will be collected during surgical resection. Blood will be drawn at various time points throughout the 2 weeks of treatment. The hypothesis is that DSP-0390 will accumulate in brain tumor tissue at pharmacologically relevant concentrations, and that alterations in cholesterol metabolism driven by mutant IDH will increase susceptibility to DSP-0390 and lead to tumor cell death.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements: * ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR * ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma. * Patient must be a candidate for surgical resection * At least 18 years of age. * Karnofsky ≥ 70% * Adequate bone marrow and organ function as defined below: * Absolute neutrophi…
Interventions
- DrugDSP-0390
DSP-0390 will be administered orally with preferably 200 mL of water, or approximately one-half cup water. The patient will take DSP-0390 after a minimum of a 6-hour fast and will fast for 1 hour after taking the dose.
Location
- Washington University School of MedicineSt Louis, Missouri