Study of DSP-0390 in Patients With Recurrent High-Grade Glioma

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    70
  • sponsor
    Sumitomo Pharma Oncology, Inc.
Updated on 7 October 2022
corticosteroids
sargramostim
dexamethasone
aptt

Summary

This is a study of DSP-0390 in patients with recurrent high grade glioma.

Description

This study will evaluate the safety and efficacy of DSP-0390 in patients with recurrent high grade glioma.

Details
Condition High Grade Glioma, Glioblastoma Multiforme
Treatment DSP-0390
Clinical Study IdentifierNCT05023551
SponsorSumitomo Pharma Oncology, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 <=2(hematologic toxicities, except
deep vein thrombosis) KPS >=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
Females of childbearing potential must have a negative serum or urine pregnancy test Male
Medical Monitor
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 <40% as determined
by ECHO or MUGA Known dysphagia, short-gut syndrome, gastroparesis, or other conditions
that limit the ingestion or gastrointestinal absorption of drugs administered orally Know
active Chrohn's or other inflammatory bowel disease History of another primary cancer
within the 2 years prior to study Day 1, except for the following: nonmelamona skin cancer
A known active acute or chronic infection including, but not limited to, HIV, HBV, and HCV
cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively
treated
[Patients who have completed a course of anti-viral treatment for HVC are eligible provided
The presence of any active retinal abnormality determined by screening tests using visual
than an HCV polymerase chain reaction shows no detectable virus] Pregnant or breastfeeding
acuity, visual field, fundoscopy, and OCT Significant cardiovascular disease, including
[Note: Female breastfeeding patients may be enrolled if they interrupt breastfeeding
NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina
Breastfeeding should not be resumed for at least 6 months after the last dose of study
poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study
drug
illness/social situations that would limit compliance with study requirements, or disorders
associated with significant immunocompromised state Major surgical procedure, surgical
resection, open biopsy, or significant traumatic injury within 4 weeks prior to study Day 1
or anticipation of need for major surgical procedure during the course of the study Minor
Day 1 Uncontrolled intercurrent illness including, but not limited to, psychiatric
surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study
Day 1 Evidence of CNS hemorrhage on baseline MRI or CT scan (except for postsurgical
asymptomatic, Gr 1 hemorrhage that has been stable at least 4 weeks for enrolled patients)
Chemotherapy or investigational anticancer therapy administered within 4 weeks (except 6
weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer)
prior to study Day 1 Radiotherapy within 12 weeks prior to study Day 1, unless relapse is
confirmed by tumor biopsy or new lesion outside of radiation field, or if there are 2 MRIs
(performed 8 weeks apart) confirming progressive disease Concurrent use of prohibited
medications: methylprednisolone, prednisone, carbamazepine, phenytoin, phenobarbital, and
other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors. These
should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1
Concurrent treatment with Tumor Treatment Field (Optune) is not allowed. Patients must stop
Optune 1 day prior to the first dose of study drug. Any wounds from Optune must be healed
Any other lung condition that in the investigators' judgement may put the patient at
History of, within 6 months of study Day 1
an increased risk for lung toxicity (including, but not limited to, suspected
adequately prior to study Day 1
Pneumonitis or interstitial lung disease
interstitial lung disease or radiation-induced lung injury)
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