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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 <=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 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 <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 Crohn's or other inflammatory bowel disease History of another primary cancer within the 2 years prior to study Day 1, except for the following: non-melamona skin cancer, cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively treated. Have a known detectable viral load for HIV or HVC, or evidence of a HBV surface antigen, all being indicative of active infection. [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 Day 1. 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: 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 adequately prior to study Day 1. History of, within 6 months of study Day 1: 1. Pneumonitis or interstitial lung disease. 2. 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05023551
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sumitomo Pharma America, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jian Li, MD
Principal Investigator Affiliation Sumitomo Pharma America, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Japan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High Grade Glioma, Glioblastoma Multiforme
Additional Details

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

Arms & Interventions

Arms

Experimental: Single arm DSP-0390

Arm Description [*] DSP-0390 by oral administration

Interventions

Drug: - DSP-0390

DSP-0390 administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Address

University of California at San Francisco

San Francisco, California, 94143

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 10032

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Hackensack, New Jersey

Status

Address

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Columbia University, New York, New York

Status

Address

Columbia University

New York, New York, 10032

Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

International Sites

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

Status

Address

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648

Kyoto University Hospital, Kyoto, Sakyo-ku, Japan

Status

Address

Kyoto University Hospital

Kyoto, Sakyo-ku, 606-8507

National Cancer Center Hospital, Chuo Ku, Tokyo, Japan

Status

Address

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045

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