Can a targeted pill slow brain tumor growth after surgery?

NCT ID NCT05592743

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Show 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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