Authorised Therapeutic confirmatory (Phase III) IDH-mutant grade 2 or 3 astrocytoma

Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy

EU CTIS ID: 2024-519404-27-00

What this study is testing

In this phase III study, the main goal is to demonstrate that vorasidenib maintenance therapy improves locally assessed PFS from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Informed consent
10. Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrolment.
11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment; a serum or urine pregnancy test must be conducted and confirmed negative within 72 hours prior to the first dose of study treatment.
12. Participants of childbearing / reproductive potential should use two adequate methods of birth control, including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment.
2. Age ≥ 18 years
3. Integrated diagnosis of astrocytoma, IDH-mutant, CNS5 WHO grade 2 or 3, per local assessment, with documented IDH1 or IDH2 mutation based on local testing of tumour tissue.

You likely can't join if

1. Presence of 1p19q co-deletion, per local assessment.
2. Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
3. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
4. Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
5. Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug

See the full eligibility criteria

Who can join

1. Informed consent
10. Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrolment.
11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment; a serum or urine pregnancy test must be conducted and confirmed negative within 72 hours prior to the first dose of study treatment.
12. Participants of childbearing / reproductive potential should use two adequate methods of birth control, including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment.
2. Age ≥ 18 years
3. Integrated diagnosis of astrocytoma, IDH-mutant, CNS5 WHO grade 2 or 3, per local assessment, with documented IDH1 or IDH2 mutation based on local testing of tumour tissue.
4. At least 1 prior surgery for glioma.
5. Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV).
6. Last chemotherapy dose of first line chemoradiotherapy more than 6 weeks and less than 12 weeks before enrolment.
7. Recovered from any clinically relevant toxicity of the previous chemoradiotherapy unless stable and manageable per investigator´s judgement
8. Adequate bone marrow, renal, and hepatic function, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at or below ULN.
9. WHO performance status 0-2

What rules you out

1. Presence of 1p19q co-deletion, per local assessment.
2. Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
3. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
4. Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
5. Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
Canada
Switzerland
Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Canada; Switzerland; Australia. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.