Vorasidenib Expanded Access Program (NCT05592743) | Clinical Trial Compass
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Vorasidenib Expanded Access Program
Plain-language summary
This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
For participants in Japan, DIM-95032-001-JPN will provide access to vorasidenib for Japanese participants aged 12 years and older with IDH1- or IDH2-mutant diffuse glioma who have undergone surgery as their only treatment and have no immediate need for radiotherapy and/or chemotherapy. Participants will receive vorasidenib once daily as long as they continue to see a benefit, do not experience unacceptable reactions, and vorasidenib is not commercially available by prescription. Enrollment will continue until vorasidenib is commercially available in Japan or until the study closes. Participants will transition off the study within approximately 3 months after vorasidenib becomes commercially available by prescription with local reimbursement (price listing) in Japan. A final safety follow-up visit is conducted 30 days after the last dose of treatment on the study.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and females; ages ≥ 12 years old.
. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis.
. At least 1 prior surgery for glioma (including biopsy).
. Adequate bone marrow function as evidenced by:
. Adequate hepatic function as evidenced by:
. Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min
. Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Be able to understand and willing to sign informed consent/assent as determined by local requirements
Exclusion criteria
. Patient is eligible for a clinical trial with vorasidenib.
0. 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.
1. Pregnant or breastfeeding.
2. Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
3. Are participating in another investigational or interventional clinical trial
4. 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)
5. Are pregnant or breast feeding
6. Are men or women who will not agree to use highly effective forms of contraception during the trial