Window of Opportunity Study of DSP-0390 in Gliomas
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.
Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.
Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF >450 msec for males and >470 msec for females); and/or the patient has a history of Torsade de Pointes.
Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption of drugs administered orally.
Trial design
Treatments tested in this trial
- DSP-0390
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Sumitomo Pharma America, Inc.
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator
Source ClinicalTrials.gov