Window of Opportunity Study of DSP-0390 in Gliomas

Early Phase 1

Not yet recruiting

• Conditions: Glioma, Malignant; Grade II Glioma; IDH Mutation
• Interventions: Drug: DSP-0390

• Registration Number: NCT06636162
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant WHO grade II or III 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...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Study Start: 2024-12-31
• Primary Completion: 2026-01-14
• Study Completion: 2026-02-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
DSP-0390 240 mg	DSP-0390	The next 10 patients will be assigned to DSP-0390 240 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.
DSP-0390 120 mg	DSP-0390	The first 10 patients will be assigned to DSP-0390 120 mg once daily by mouth for 2 weeks prior to surgical resection, with the final dose being administered the morning of surgery.

Primary Outcome Measures

Name	Time	Method
Unbound DSP-0390 concentration in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Unbound DSP-0390 concentration in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in DSP-0390 concentration in plasma	From start of treatment through end of treatment (estimated to be 2 weeks)	Unbound DSP-0390 concentration in plasma will be quantified using blood samples taken throughout treatment.

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3 or higher study drug related adverse events (AEs)	From start of treatment through 30 day follow-up (estimated to be 6 weeks)	Assessed using CTCAE v5.0
Lathosterol levels in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Lathosterol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Zymostenol levels in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	Zymostenol levels in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Lathosterol/zymostenol (L/Z) ratio in non-enhancing tumor tissue	At time of surgery following treatment (estimated to be 2 weeks)	L/Z ratio in non-enhancing tumor tissue will be quantified using tissue removed during resection after treatment.
Changes in lathosterol levels in blood	From start of treatment through surgical resection (estimated to be 2 weeks)	Change in lathosterol levels in blood will be quantified after surgical resection.
Changes in zymostenol levels in blood	From start of treatment through surgical resection (estimated to be 2 weeks)	Change in zymostenol levels in blood will be quantified after surgical resection.
Changes in L/Z ratio in blood	From start of treatment through surgical resection (estimated to be 2 weeks)	Change in L/Z ratio in blood will be quantified after surgical resection.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States