GliomaNCT05592743
Vorasidenib Expanded Access Program
A study testing Vorasidenib in people with Glioma and Recurrence, run by Servier.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Glioma, Recurrence, Disease Attributes
- What is being tested?
- Vorasidenib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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:
- Absolute neutrophil count ≥ 1.5 X 109/L
- Hemoglobin ≥ 9 g/dL
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- Platelets ≥ 100 X 109/L
- 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
- 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:
- Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician
- Be able to understand and willing to sign informed consent/assent as determined by local requirements
Who cannot join
- Patient is eligible for a clinical trial with vorasidenib.
- 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.
- Pregnant or breastfeeding.
- 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:
- Are participating in another investigational or interventional clinical trial
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- 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)
- Are pregnant or breast feeding
- Are men or women who will not agree to use highly effective forms of contraception during the trial
- Have Grade 4 astrocytoma
- Are taking strong CYP1A2 inhibitors like fluvoxamine maleate (Luvox, Depromel), etc
About this study
Official title: The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment
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.
Read the detailed description
This section does not apply to participants in Japan.
This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.
Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated.
Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.
- Conditions
- Glioma, Recurrence, Disease Attributes, Pathologic Processes, Neoplasms, Neuroepithelial, Neuroectodermal Tumors
- Being tested
- Vorasidenib
- Keywords
- Vorasidenib, AG-881, S95032, Glioma, Oligodendroglioma, Astrocytoma, IDH-1, IDH-2
- Medical subject headings
- Glioma, Recurrence, Disease Attributes, Pathologic Processes, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorasidenibDrug
Also called AG-881, S95032
Oral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Servier
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Servier Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Jonathan Dewey, MD, Study director, Servier Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592743
- Sponsor's protocol ID
- VORA-EAP
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment
- ClinicalTrials.gov ID
- NCT05592743
- Acronym / sponsor ID
- VORA-EAP
- Conditions
- Glioma, Recurrence, Disease Attributes, Pathologic Processes, Neoplasms, Neuroepithelial, Neuroectodermal Tumors
- Keywords
- Vorasidenib, AG-881, S95032, Glioma, Oligodendroglioma, Astrocytoma, IDH-1, IDH-2
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- ServierIndustry (pharma, biotech, devices)
- Collaborators
- Servier Pharmaceuticals, LLC
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This section does not apply to participants in Japan.
This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.
Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated.
Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (11 listed)
- Patient is eligible for a clinical trial with vorasidenib.
- 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.
- Pregnant or breastfeeding.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VorasidenibAlso: AG-881, S95032Oral therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Dewey, MD study director
Servier Pharmaceuticals, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Vorasidenib in people with Glioma and Recurrence, run by Servier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.