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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DSP-0390
DrugDSP-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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Arm A Low Grade Gliomas: DSP-0390 120 mgExperimental treatment 0 interventions
Group B: Arm B High Grade Gliomas: DSP-0390 180 mgExperimental treatment 0 interventions
Trial outcomes
Primary outcomes
1
Unbound DSP-0390 concentration in non-enhancing tumor tissue
Unbound DSP-0390 concentration in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Time frame
At time of surgery following treatment (estimated to be 2 weeks)2
Changes in DSP-0390 concentration in plasma
Unbound DSP-0390 concentration in plasma will be quantified using blood samples taken throughout treatment.
Time frame
From start of treatment through end of treatment (estimated to be 2 weeks)Secondary outcomes
1
Incidence of treatment emergent adverse events (TEAEs)
Assessed using CTCAE v5.0
Time frame
From start of treatment through 30 day follow-up (estimated to be 6 weeks)2
Incidence of grade 3 or higher study drug related adverse events (AEs)
Assessed using CTCAE v5.0
Time frame
From start of treatment through 30 day follow-up (estimated to be 6 weeks)3
Lathosterol levels in non-enhancing tumor tissue
Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Time frame
At time of surgery following treatment (estimated to be 2 weeks)4
Changes in lathosterol levels in non-enhancing tumor tissue
Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Time frame
Baseline and at time of surgery following treatment (estimated to be 2 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Sumitomo Pharma America, Inc.
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator
Source ClinicalTrials.gov