Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationPhase 2NCT07286292
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
A Phase 2 study testing Vorasidenib in people with Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 5 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or IDH2 mutation. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
- What is being tested?
- Vorasidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 23 Jul 2026to 2 May 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weigh ≥ 25 kg at Screening.
- Written informed consent/assent must be obtained from a legally authorized representative, and assent must be obtained from the participant in accordance with local regulations. Participants and their families must be willing and able to comply with the scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study.
- Have Grade 2 astrocytoma or oligodendroglioma per World Health Organisation (WHO) 2021 criteria.
- Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection) and no other prior anticancer therapy, including chemotherapy and radiotherapy, and do not need immediate chemotherapy or radiotherapy in the opinion of the Investigator.
- Have:
- Confirmed IDH1 or IDH2 gene mutation, as well as known 1p19q and/or ATRX (Alpha Thalassemia/Mental Retardation Syndrome X-linked) status based on local testing of tumor tissue by an accredited laboratory.
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- For astrocytoma: Absence of 1p19q co-deletion and/or documented loss of nuclear ATRX expression or ATRX mutation by local testing.
- For oligodendroglioma: Presence of 1p19q co-deletion by local testing.
- Have magnetic resonance imaging (MRI)-evaluable, measurable, non-enhancing disease
- Have a Karnofsky Performance Score (KPS; for participants ≥ 16 years of age) or Lansky Play-Performance Scale (LPPS; for participants < 16 years of age) score of ≥ 70. Karnofsky Performance Score and LPPS < 70 due to functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted.
- Have adequate bone marrow function as evidenced by:
- Absolute neutrophil count ≥ 1500/mm3 or ≥ 1.5 × 109/L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000/mm3 or ≥ 100 × 109/L
- Have adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.5 × ULN; if > 1.5 ULN and due to Gilbert syndrome, total bilirubin ≤ 3 × ULN with direct bilirubin ≤ ULN
- AST at or below ULN and ALT at or below ULN
- Alkaline phosphatase (ALP) ≤ 2.5 × ULN
- Have adequate renal function as evidenced by:
- Serum creatinine ≤ 2.5 × ULN, OR
- eGFR > 40 mL/min/1.73 m2 based on the Bedside Schwartz method 0.413 × (Height in cm/Serum Creatinine in mg/dL)
- Have recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management (functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted).
- Female participants of reproductive potential must have a negative serum pregnancy test before starting investigational medicinal product (IMP).
- Women of childbearing potential as well as fertile male participants with female partners of reproductive potential, must agree to abstain from sexual intercourse or to use 2 effective methods of contraception from screening until at least 90 days after the last dose of IMP.
Who cannot join
- Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including, but not limited to, systemic chemotherapy, radiotherapy, vaccines, small molecule inhibitors, IDH inhibitors, and investigational agents.
- Have features assessed as high-risk by the Investigator.
- Have leptomeningeal disease.
- Concurrent active malignancy except for curatively resected nonmelanoma skin cancer or curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
- Unable to swallow oral medication.
- Are pregnant or breastfeeding.
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- Are participating in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed.
- Have a severe or uncontrolled active acute or chronic infection or an unexplained fever > 38.5°C within 7 days of C1D1.
- Have a known hypersensitivity to any of the components of vorasidenib.
- Have significant active cardiac disease within 6 months before the start of IMP, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
- Have a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events.
- Are taking therapeutic doses of steroids (defined as > 1.5 mg/day dexamethasone or >10 mg/day prednisone or equivalent) for signs/symptoms of glioma. Participants taking physiologic doses (defined as ≤ 1.5 mg/day dexamethasone or ≤ 10 mg/day prednisone or equivalent) for medical conditions not related to glioma will be permitted.
- Are taking any medications that are CYP2C19 or CYP3A substrates with a narrow therapeutic index or strong inhibitors of CYP1A2.
- Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus (HIV) antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV or HIV that is adequately suppressed by institutional practice will be permitted.
- Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).
- Have any other acute or chronic medical or psychiatric condition.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Institut de Recherches Internationales Servier (I.R.I.S.) contact
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Dana Farber (DFCI)
Boston, Massachusetts, 02115
- Recruiting
Lurie Children' sNWU
Chicago, Illinois, 60611
- Recruiting
UCLA
Los Angeles, California, 90095
- Recruiting
Children's Minnesota
Minneapolis, Minnesota, 55404
Australia1 site, 1 recruiting
- Recruiting
Kids Cancer Centre, Sydney Children's Hospital Randwick
Sydney, 2031
David Ziegler
About this study
Official title: A Phase 2, Single Arm, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vorasidenib in Pediatric Participants Aged 12 to < 18 Years Old With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or IDH2 mutation. The study includes a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term follow-up period. The long-term follow-up period will assess participants for growth, development, and long-term safety impacts for approximately 5 years after the start of treatment or until Tanner Stage V is reached (whichever is later). Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), imaging (MRI, X-ray), vital sign checks, and physical exams.
- Being tested
- Vorasidenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorasidenibDrug
40mg taken orally daily for participants weighing ≥ 40 kg OR 20mg taken orally daily for participants weighing ≥ 25 kg to < 40 kg
| Study group | Role | What they receive |
|---|---|---|
| Open Label Vorasidenib | Experimental | Not described Receives: Drug: Vorasidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death
Measured: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Severity of AEs
As assessed by the NCI-CTCAE version 5.0.
Measured: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Height and Weight Percentiles at Study Visits
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change in Height and Weight Percentiles from Cycle 1 Day 1 (C1D1)
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Tanner staging
Tanner stages represent puberty progression from stage 1 being the prepubertal form to stage 5 representing the final adult form.
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Average age of menarche
Historically and/or while on treatment, if applicable
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of leutenizing hormone (LH)
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of follicle-stimulating hormone (FSH)
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of anti-Müllerian hormone (AMH)
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of estradiol
For females only
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of testosterone
For males only
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of Insulin-like growth factor 1 (IGF-1)
Measured: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Insulin-Like Growth Factor-Binding Protein 3 (IGFBP-3)
Measured: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of thyroid stimulating hormone (TSH)
Measured: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Free T4 (thyroxine)
Measured: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment hand/wrist bone age as determined by X-ray
Measured: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Secondary outcomes (9)
Progression-free survival (PFS)
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Objective response (OR)
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Best overall response of complete response (CR), partial response (PR), or minor response (mR)
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Time to response (TTR)
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Time to CR, PR, or mR
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Duration of response (DoR)
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Duration of CR, PR, or mR
Measured: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Plasma concentration of vorasidenib
Measured: Through Cycle 3 Day 1 (C3D1) (each cycle is 28 days long)
Plasma concentration of AGI-69460
Measured: Through Cycle 3 Day 1 (C3D1) (each cycle is 28 days long)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start23 Jul 2026
- Primary completion2 May 2033 (estimated)
- Study completion2 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286292
- Sponsor's protocol ID
- S095032-236
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vorasidenib in Pediatric Participants Aged 12 to < 18 Years Old With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
- ClinicalTrials.gov ID
- NCT07286292
- Acronym / sponsor ID
- S095032-236
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 2 May 2033 (estimated)
- Study completion
- 2 May 2033 (estimated)
- First posted
- 16 Dec 2025 (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.
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or IDH2 mutation. The study includes a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term follow-up period. The long-term follow-up period will assess participants for growth, development, and long-term safety impacts for approximately 5 years after the start of treatment or until Tanner Stage V is reached (whichever is later). Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), imaging (MRI, X-ray), vital sign checks, and physical exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Vorasidenib | Experimental | Drug: Vorasidenib |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- Weigh ≥ 25 kg at Screening.
- Written informed consent/assent must be obtained from a legally authorized representative, and assent must be obtained from the participant in accordance with local regulations. Participants and their families must be willing and able to comply with the scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study.
- Have Grade 2 astrocytoma or oligodendroglioma per World Health Organisation (WHO) 2021 criteria.
- Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection) and no other prior anticancer therapy, including chemotherapy and radiotherapy, and do not need immediate chemotherapy or radiotherapy in the opinion of the Investigator.
- Have:
Key exclusion criteria (16 listed)
- Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including, but not limited to, systemic chemotherapy, radiotherapy, vaccines, small molecule inhibitors, IDH inhibitors, and investigational agents.
- Have features assessed as high-risk by the Investigator.
- Have leptomeningeal disease.
- Concurrent active malignancy except for curatively resected nonmelanoma skin cancer or curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
- Unable to swallow oral medication.
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 |
|---|---|---|
| Vorasidenib40mg taken orally daily for participants weighing ≥ 40 kg OR 20mg taken orally daily for participants weighing ≥ 25 kg to < 40 kg | Drug | Open Label Vorasidenib |
Primary outcome
Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death
Time frame: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Severity of AEs
Time frame: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
As assessed by the NCI-CTCAE version 5.0.
Height and Weight Percentiles at Study Visits
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change in Height and Weight Percentiles from Cycle 1 Day 1 (C1D1)
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Tanner staging
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Tanner stages represent puberty progression from stage 1 being the prepubertal form to stage 5 representing the final adult form.
Average age of menarche
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Historically and/or while on treatment, if applicable
Change from C1D1 to the worst on-treatment value of leutenizing hormone (LH)
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of follicle-stimulating hormone (FSH)
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of anti-Müllerian hormone (AMH)
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Change from C1D1 to the worst on-treatment value of estradiol
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
For females only
Change from C1D1 to the worst on-treatment value of testosterone
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
For males only
Change from C1D1 to the worst on-treatment value of Insulin-like growth factor 1 (IGF-1)
Time frame: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Insulin-Like Growth Factor-Binding Protein 3 (IGFBP-3)
Time frame: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of thyroid stimulating hormone (TSH)
Time frame: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Free T4 (thyroxine)
Time frame: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment hand/wrist bone age as determined by X-ray
Time frame: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
9 secondary outcomes
Progression-free survival (PFS)
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Objective response (OR)
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Best overall response of complete response (CR), partial response (PR), or minor response (mR)
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Time to response (TTR)
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Time to CR, PR, or mR
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Duration of response (DoR)
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Duration of CR, PR, or mR
Time frame: Through PFS follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)
Plasma concentration of vorasidenib
Time frame: Through Cycle 3 Day 1 (C3D1) (each cycle is 28 days long)
Plasma concentration of AGI-69460
Time frame: Through Cycle 3 Day 1 (C3D1) (each cycle is 28 days long)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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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.
Institut de Recherches Internationales Servier (I.R.I.S.) contact
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vorasidenib in people with Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 5 sites in 2 countries.
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 24 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institut de Recherches Internationales Servier (I.R.I.S.) (+33 1 55 72 60 00, scientificinformation@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death (time frame: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 8 Sep 2026.