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New treatment option for IDH-mutant Grade 2 or 3 Astrocytoma
Official title Vorasidenib Maintenance for IDH Mutant Astrocytoma
ClinicalTrials.gov ID: NCT06809322
What this study is testing
What is Vorasidenib?
Vorasidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idh-mutant grade 2 or 3 astrocytoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (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. The primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment using the RANO 2.0 criteria.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Before participant's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Age ≥ 18 years
- Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
- Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
- At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection)
You likely can't join if
- Presence of 1p19q co-deletion, per local assessment.
- Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
- Last chemotherapy dose of first line chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment
- Prior therapy with an IDH inhibitor or IDH vaccine
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment...
- Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
See the full eligibility criteria
- Before participant's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Age ≥ 18 years
- Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
- Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
- At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection)
- 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).
- Adequate bone marrow function: absolute neutrophil counts ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets 100 x 109/ L.
- Adequate renal function: serum creatinine ≤ 2.0 x ULN, or creatine clearance \> 40 mL/min, as calculated based on CKD-EPI 2021 formula.
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin ≥1.5 × ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x ULN.
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN.
- Recovered from any clinically relevant toxicity of the previous chemoradiotherapy cycle unless stable and manageable per investigator´s judgement
- WHO performance status 0-2
- Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment.
- Baseline brain MRI available, as defined in the schedule of assessments
- Available FFPE tumour tissue from prior neurosurgery for central biobanking and translational research
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment.
- 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...
- Presence of 1p19q co-deletion, per local assessment.
- Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
- Last chemotherapy dose of first line chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment
- Prior therapy with an IDH inhibitor or IDH vaccine
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
- Pregnancy or breastfeeding
- Significant known active cardiac disease within 6 months before enrollment, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
- Known hypersensitivity to any of the components of vorasidenib.
- 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.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV...
- Known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the gastrointestinal absorption...
- Inability or known contraindication to undergo contrast media MRI.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient...
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Austria
- Linz, Austria
- Vienna, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Brno, Czechia
- Bordeaux, France
- Lyon, France
- Marseille, France
- Paris, France
- Toulouse, France
- Bonn, Germany
- Frankfurt, Germany
- Heidelberg, Germany
- Mannheim, Germany
- Regensburg, Germany
- Bologna, Italy
- Padova, Italy
- Roma, Italy
+ 12 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Austria; Linz, Austria; Vienna, Austria; Brussels, Belgium; Ghent, Belgium; Leuven, Belgium and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.