Clin2
NCT07791264Possibly a fitNot yet recruiting

FPS-ZM1 with or without dexamethasone for brain swelling after glioblastoma surgery

GlioblastomaMalignant GliomaRecurrent GlioblastomaRecurrent Malignant Glioma

Treatments studied

Part of Cancer clinical trials.

This trial tests a new drug called FPS-ZM1, with or without a steroid (dexamethasone), to see if it helps control brain swelling after surgery for glioblastoma. You will take the study drug before and after your planned surgery, and the study will check how safe and effective it is.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
24 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older.
  • You need a diagnosis of glioblastoma or a high-grade brain tumor, confirmed by imaging or biopsy.
  • You must be planning to have surgery to remove as much of the tumor as possible.
  • Your brain MRI must show mild to moderate swelling (midline shift less than 10 mm).
  • You must be able to reduce your steroid (dexamethasone) dose as specified: to 6 mg or less per day (if in dose levels 1-3) or to 1 mg or less per day (if in dose level 4) before surgery.
  • You need adequate organ function: blood counts (ANC ≥ 1,000, platelets ≥ 100,000, hemoglobin ≥ 9), liver tests (bilirubin ≤ 1.5x normal, AST/ALT ≤ 1.5x normal), kidney function (eGFR ≥ 60), and normal blood clotting tests.
  • Your heart's electrical activity (QTc interval) must be within a safe range (≤ 450 ms).
  • If you are of childbearing potential, you must agree to use effective birth control during the study and for at least 3 months after the last dose.
  • You must be willing to stop medications that interfere with the study drug (strong inducers or inhibitors of CYP450, drugs that affect the heart rhythm) at least 14 days before starting treatment.
  • You must not have an active infection, be pregnant or breastfeeding, or have significant uncontrolled medical conditions.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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