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Active Not Recruiting
NCT05023551
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
Conditions: High Grade Glioma, Glioblastoma Multiforme
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 39
Sponsor: Sumitomo Pharma America, Inc.
Location: University of California at San Francisco San Francisco California
Summary
This is a study of DSP-0390 in patients with recurrent high grade glioma.
Eligibility Criteria
Inclusion Criteria:
Estimated life expectancy \>+3 months Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade \=70%
Adequate organ function as determined by:
* Absolute Neutrophil ≥1500/microliter (may not use G-CSF or GM CSF)
* Platelet ≥100 × 103/microliter
* Hemoglobin ≥9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
* Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault)
* Total bilirubin ≤1.5 times ULN (or ≤ 2 times ULN for patients with known Gilbert's syndrome)
* AST ≤ 3 times ULN
* ALT ≤ 3 times ULN
* INR, PT, PTT, or aPTT ≤1.5 x ULN Note: The use of anticoagulants is permitted as long as the PT/(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to study Day 1.
If on antiepileptic drug; dose must be stable and no seizures 14 days prior to study Day 1 If on corticosteroids at baseline, dose must be stable or decreasing for at least 5 days prior to study Day 1. For the dose expansion part of the study, the dose must be ≤ 4 mg dexamethasone per day (or equivalent dose if other corticosteroids are used). A higher stable dose of corticosteroids, if used as HRT, may be allowed upon discussion with the Medical Monitor.
Females of childbearing potential must have a negative serum or urine pregnancy test Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures or agreement to refrain completely from heterosexual intercourse during the study and for 6 months (females \& males) after the last dose of study drug
Exclusion Criteria:
Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to study Day 1, Multifocal disease, leptomeningeal metastasis, or extracranial metastasis Abnormal ECGs that are clinically significant, including those where QT prolongation (QTcF\>450 msec for males and \>470 msec for females); and/or history of Torsade de Pointes Left ventricular ejection fraction \
Source: ClinicalTrials.gov (NCT05023551). StuddyBuddy aggregates publicly available trial information.