Testing a daily pill called vorasidenib for IDH-mutant astrocytoma after first treatment
Official title: Vorasidenib Maintenance for IDH Mutant Astrocytoma
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This trial is testing whether a daily pill can hold off tumor growth longer than a placebo pill.
Read our full plain-language summary
What the trial team says
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. In this a comparative, randomized (1:1), triple blinded, multicentre phase III superiority trial with one stopping rule for efficacy and futility after end of enrolment, participants in the experimental arm will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles while participants in the control arm will receive a matched oral placebo once daily in continuous 28-day cycles
Key facts
- Registry number
- NCT06809322
- Stage of testing
- Phase 3
- Conditions studied
- IDH-mutant Grade 2 or 3 Astrocytoma
Where it is running
This trial lists 59 sites.
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Alberta
- Arthur J.E. Child Comprehensive Cancer Centre (Calgary)
- Cross Cancer Institute (Edmonton)
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Australia
- Flinders Medical Centre / Southern Adelaide Local Health Network (Bedford Park)
- Chris O'Brien LifeHouse (Camperdown)
- Austin Hospital (Heidelberg)
- Royal Hobart Hospital (Hobart)
- Liverpool Hospital (Liverpool)
- Peter MacCallum Cancer Centre (Melbourne)
- the Alfred hospital (Melbourne)
- Sir Charles Gairdner Hospital (Nedlands)
- Royal North Shore Hospital (St Leonards)
- Princess Alexandra Hospital (Woolloongabba)
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Austria
- Medical University of Innsbruck (Innsbruck)
- Kepler University Hospital - Neuromed campus (Linz)
- Medical University of Vienna (Vienna)
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Belgium
- Universitair Ziekenhuis Brussel (Brussels)
- Ghent University Hospital (Ghent)
- U.Z. Leuven - Campus Gasthuisberg (Leuven)
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British Columbia
- BC Cancer Agency - Vancouver (Vancouver)
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Czechia
- Masaryk Memorial Cancer Institute (Brno)
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France
- Universitary hospital Bordeaux France (Bordeaux)
- CHU Lyon - Hopital neurologique Pierre Wertheimer (Lyon)
- Marseille APHM (Marseille)
- Assistance Publique Hopitaux de Paris APHP - Sorbonne (Paris)
- Oncopole Claudius Regaud, IUCT-Oncopole (Toulouse)
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Germany
- Universitaskliniken Bonn (Bonn)
- University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt)
- NNeurology department heidelberg (Heidelberg)
- Mannheim University Hospital (Mannheim)
- Universitaetsklinikum Regensburg (Regensburg)
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Italy
- Bellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di Bologna (Bologna)
- Veneto Institute of Oncology (Padova)
- Sapienza University (Roma)
- AOU Citta della Salute e della Scienza di Torino (Torino)
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Manitoba
- CancerCare Manitoba (Winnipeg)
-
Netherlands
- Amsterdam UMC location VUMC (Amsterdam)
- Academisch Ziekenhuis Maastricht (Maastricht)
- Erasmus MC (Rotterdam)
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Nova Scotia
- QEII Health Sciences Centre Capital District Health Authority (Halifax)
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Ontario
- Juravinski Cancer Centre at Hamilton Health Sciences (Hamilton)
- Kingston Health Sciences Centre (Kingston)
- London Health Sciences Centre Research Inc. (London)
- Ottawa Hospital Research Institute (Ottawa)
- Odette Cancer Centre Sunnybrook Health Sciences Centre (Toronto)
- University Health Network Princess Margaret Cancer Centre (Toronto)
-
Quebec
- CHUM-Centre Hospitalier de l'Universite de Montreal (Montreal)
- Montreal Neurological Institute and Hospital James Administration Building (Montreal)
- CIUSSS NIM - Hôpital du Sacré-Cœur de Montréal (Montreal)
- Hotel-Dieu de Quebec (Québec)
- CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke (Sherbrooke)
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Spain
- Hospital de Sant Pau i La Santa Creu (Barcelona)
- Vall de Hebron Hospital (Barcelona)
- Hospital Universitario 12 de Octubre (Madrid)
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Switzerland
- University Hospital Basel (Basel)
- University Hospital Zurich (Zurich)
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United Kingdom
- Queen Elizabeth Hospital Birmingham (Birmingham)
- The Christie NHS Foundation Trust (Manchester)
- Clatterbridge Cancer Centre (Metropolitan Borough of Wirral)
- Royal Marsden Hospital (Surrey Quays)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.