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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    70
  • sponsor
    Sumitomo Dainippon Pharma Oncology, Inc
Updated on 8 December 2021
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, Glioblastoma multiforme, malignant glioma, glioblastoma
Treatment DSP-0390
Clinical Study IdentifierNCT05023551
SponsorSumitomo Dainippon Pharma Oncology, Inc
Last Modified on8 December 2021

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 the first study treatment
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 enrollment. 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 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 enrollment, except for the following: nonmelamona skin
cancer, cervical carcinoma in situ, superficial bladder cancer that has been
removed or curatively treated
A known active acute or chronic infection including, but not limited to, HIV
HBV, and HCV Pregnant or breastfeeding. [Note: Female breastfeeding patients
may be enrolled if they interrupt breastfeeding. Breastfeeding should not be
resumed for at least 6 months after the last dose of study drug
The presence of any active retinal abnormality determined by screening tests
using visual acuity, visual field, fundoscopy, and OCT Significant
cardiovascular disease, including NYHA Class III or IV congestive heart
failure, myocardial infarction, unstable angina, poorly controlled cardiac
arrhythmias, or stroke in the preceding 6 months prior to study enrollment
Uncontrolled intercurrent illness including, but not limited to, psychiatric
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 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
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 adequately prior to enrollment in this study
History of, within 6 months of study Day 1
Pneumonitis or interstitial lung disease
Any other lung condition that in the investigators' judgement may put the patient at an increased risk for lung toxicity (including, but not limited to, suspected interstitial lung disease or radiation-induced lung injury)
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