Can a targeted pill slow brain tumor growth after surgery?
NCT ID NCT05592743
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This expanded access program offers vorasidenib, an oral drug, to people aged 12 and older with IDH-mutated glioma who have had surgery. The drug targets specific genetic mutations in tumor cells. The goal is to see if it can help control the disease without immediate need for radiation or chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vorasidenib, an oral drug that targets IDH mutations in glioma cells
- What this could lead to
- If it works, vorasidenib could offer a way to delay or avoid chemotherapy and radiation for people with certain brain tumors.
- What could go wrong
- This is an expanded access program, not a controlled trial, so results may be less clear. Side effects are possible, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and females; ages ≥ 12 years old. 2. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis. 3. At least 1 prior surgery for glioma (including biopsy). 4. Adequate bone marrow function as evidenced by: * Absolute neutrophil count ≥ 1.5 X 109/L * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100 X 109/L 5. Adequate hepatic function as evidenced by: * Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) * Aspartate aminotransferase and alanine aminotransferase: at or below the ULN * Alkaline phosphatase ≤ 2.5 X ULN 6. Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min For participants in Japan, all the above inclusion criteria apply, as well as #7 and #8 below: 7. Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician 8. Be able to understand and willing to sign informed consent/assent as determined by local requirements Exclusion criteria: 9. Patient is eligible for a clinical trial with vorasidenib. 10. Patients who are enrolled in a Servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment. 11. Pregnant or breastfeeding. 12. Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors. For participants in Japan, the above exclusion criteria do NOT apply. The applicable exclusion criteria for Japan are listed as #13 through #18 below: 13. Are participating in another investigational or interventional clinical trial 14. Have had any prior anticancer therapy other than surgery for treatment of glioma including systemic chemotherapy, radiotherapy, IDH inhibitors, and other anticancer therapies (investigational agents) 15. Are pregnant or breast feeding 16. Are men or women who will not agree to use highly effective forms of contraception during the trial 17. Have Grade 4 astrocytoma 18. Are taking strong CYP1A2 inhibitors like fluvoxamine maleate (Luvox, Depromel), etc
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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