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New treatment option for Glioma, Malignant
Official title Window of Opportunity Study of DSP-0390 in Gliomas
ClinicalTrials.gov ID: NCT06636162
What this study is testing
What is DSP-0390?
DSP-0390 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioma, malignant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant glioma undergoing tumor resection. Tissue will be collected during surgical resection.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed...
- ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR
- ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma.
- Patient must be a candidate for surgical resection
- At least 18 years of age.
You likely can't join if
- Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.
- Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.
- Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \>450 msec for...
- Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption...
- Patient is known to have active Crohn's or other inflammatory bowel disease.
- A history of other malignancy for which all treatment was completed at least 2 years before Day 1 and the patient has no evidence of disease...
See the full eligibility criteria
Who can join
- Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:
- ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR
- ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma.
- Patient must be a candidate for surgical resection
- At least 18 years of age.
- Karnofsky ≥ 70%
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm (patient may not use G-CSF or GM-CSF to achieve this ANC level)
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9 g/dL (patient may not receive transfusion or use erythropoietin to obtain this Hgb level)
- Total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with known Gilbert's syndrome)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), or activated partial thromboplastin time (aPTT) ≤1.5 x ULN. The use of anticoagulants is permitted as long as the PT/(a)PTT...
- Creatinine Clearance of ≥40 mL/min per Cockroft-Gault formula or by a 24 hour urine.
- If a patient is using an antiepileptic medication, the patient is on a stable dose and without seizures for 14 days prior to Day 1. The antiepileptic medication used must not fall under any prohibited therapy category...
- If the patient is receiving corticosteroids at baseline, the dose administered is stable or decreasing for at least 5 days prior to Day 1. A higher stable dose of corticosteroids, if used as hormone replacement therapy...
- The effects of DSP-0390 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (2 forms of acceptable contraception, including one...
- Ability to understand and willingness to sign an IRB approved written informed consent document.
What rules you out
- Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.
- Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.
- Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \>450 msec for males and \>470 msec for females); and/or the patient has a history...
- Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Patient is known to have active Crohn's or other inflammatory bowel disease.
- A history of other malignancy for which all treatment was completed at least 2 years before Day 1 and the patient has no evidence of disease. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, and...
- On active treatment for other, unrelated malignancy or currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390.
- Patient has taken concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors within 1 week or 5 half-lives...
- The presence of any active retinal abnormality determined by screening ophthalmologic examination.
- Patient has significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, pectoris, clinically significant cardiac...
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, disorders associated with significant immunocompromised state...
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of DSP-0390.
- Patients with HIV are eligible unless their CD4+ T-cell counts are \<350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with...
- Patient has a known detectable viral load for hepatitis C, or evidence of a hepatitis B surface antigen.
- Patient has had a major non-neurologic surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1 or anticipates needing a major surgical procedure during the...
- Patient has had a minor surgical procedure, fine needle aspirations, or core biopsies within 7 days prior to Day 1.
- Patient has received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1.
- Patient has had radiotherapy within 12 weeks prior to Day 1, unless relapse is confirmed by tumor biopsy.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.