Glioblastoma study: Lixumistat - Cohort
Official title Window of Opportunity Study of Lixumistat in Patients With Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT07884344
What this study is testing
What is Lixumistat?
This is an investigational oral medicine being studied as a potential treatment for glioblastoma.
Also referred to as IM156.
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 aims to see how the drug Lixumistat affects patients with newly diagnosed glioblastoma.
- Who it's for
- People who have just been diagnosed with glioblastoma.
- What's involved
- Participants will receive Lixumistat and undergo medical tests to monitor their health.
- Time commitment
- The duration and specific visit schedule are not provided in the source text.
- 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
- Patient must be ≥18 years of age.
- Patients with newly-diagnosed Glioblastoma (GBM) for whom neurosurgical tumor resection is indicated and planned according to the assessment of the...
- Patient must have Karnofsky Performance Status (KPS) ≥ 70.
- Magnetic resonance imaging (MRI) scan performed within 21 days prior to starting protocol treatment.
- For women (any individual assigned female at birth) who are not postmenopausal (i.e., \< 2 years after last menstruation) or surgically sterile...
You likely can't join if
- Known histological diagnosis of malignant brain tumor other than Glioblastoma (GBM).
- Patients who are unable to undergo contrast-enhanced MRI for any reason (for example, patients with a glomerular filtration rate [GFR] \< 30 mL/min...
- Patients who are receiving any other investigational agents for GBM treatment.
- Received any prior treatment for GBM.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lixumistat.
- Patients with uncontrolled intercurrent illness.
See the full eligibility criteria
- Patient must be ≥18 years of age.
- Patients with newly-diagnosed Glioblastoma (GBM) for whom neurosurgical tumor resection is indicated and planned according to the assessment of the treating physician as per treating physician or neurosurgeon.
- Patient must have Karnofsky Performance Status (KPS) ≥ 70.
- Magnetic resonance imaging (MRI) scan performed within 21 days prior to starting protocol treatment.
- For women (any individual assigned female at birth) who are not postmenopausal (i.e., \< 2 years after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active, agreement...
- Male patients (any individual assigned male at birth) of reproductive potential must avoid pregnancy in partners who are women of childbearing potential, and such partners should not consider getting pregnant during the...
- Patient understands the procedures and investigational nature of the trial medication and agrees to comply with trial requirements by providing written informed consent.
- Life expectancy ≥ 3 months at the start of treatment in the opinion of the Investigator.
- Absolute neutrophil count (ANC) ≥ 1000 cells/µL
- Hemoglobin \>8 g/dL (Patients are allowed to be transfused to this level)
- Platelets ≥100 × 109 platelets/L.
- Serum total bilirubin ≤1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the Lead Principal Investigator
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)): ≤3 × institutional ULN
- Creatinine clearance \>30 mL/min (patients with mild or moderate renal impairment) based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation or alternative estimation of renal function, such as Modified...
- Known histological diagnosis of malignant brain tumor other than Glioblastoma (GBM).
- Patients who are unable to undergo contrast-enhanced MRI for any reason (for example, patients with a glomerular filtration rate [GFR] \< 30 mL/min, patients with a pacemaker that is incompatible with MRI, have metallic...
- Patients who are receiving any other investigational agents for GBM treatment.
- Received any prior treatment for GBM.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lixumistat.
- Patients with uncontrolled intercurrent illness.
- Patient on medications with a similar mechanism of action (i.e., oxidative phosphorylation inhibitors) to Lixumistat including the anti-diabetic medication metformin.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, 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, but 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?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.