Vorasidenib Maintenance for IDH Mutant Astrocytoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Vorasidenib: Vorasidinib will be administered orally once daily at a dose of 40 mg in continuous 28-day cycles
Vorasidenib Placebo: Matched oral vorasidenib placebo will be administered once daily in continuous 28-day cycles
Study summary
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
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) by local assessment — ~7.7 years and 10.5 years from first patient in
Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS.
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| Flinders Medical Centre / Southern Adelaide Local Health Network | Bedford Park | Australia | Not Yet Recruiting |
| Chris O'Brien LifeHouse | Camperdown | Australia | Not Yet Recruiting |
| Austin Hospital | Heidelberg | Australia | Not Yet Recruiting |
| Royal Hobart Hospital | Hobart | Australia | Not Yet Recruiting |
| Liverpool Hospital | Liverpool | Australia | Not Yet Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Australia | Not Yet Recruiting |
| the Alfred hospital | Melbourne | Australia | Not Yet Recruiting |
| Sir Charles Gairdner Hospital | Nedlands | Australia | Not Yet Recruiting |
| Royal North Shore Hospital | St Leonards | Australia | Not Yet Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Australia | Recruiting |
| Medical University of Innsbruck | Innsbruck | Austria | Recruiting |
| Kepler University Hospital - Neuromed campus | Linz | Austria | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Universitair Ziekenhuis Brussel | Brussels | Belgium | Recruiting |
| Ghent University Hospital | Ghent | Belgium | Recruiting |
| U.Z. Leuven - Campus Gasthuisberg | Leuven | Belgium | Recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Alberta | Not Yet Recruiting |
| Cross Cancer Institute | Edmonton | Alberta | Not Yet Recruiting |
| BC Cancer Agency - Vancouver | Vancouver | British Columbia | Not Yet Recruiting |
| CancerCare Manitoba | Winnipeg | Manitoba | Recruiting |
| QEII Health Sciences Centre Capital District Health Authority | Halifax | Nova Scotia | Not Yet Recruiting |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | Not Yet Recruiting |
| Kingston Health Sciences Centre | Kingston | Ontario | Not Yet Recruiting |
| London Health Sciences Centre Research Inc. | London | Ontario | Not Yet Recruiting |
| Ottawa Hospital Research Institute | Ottawa | Ontario | Not Yet Recruiting |
| Odette Cancer Centre Sunnybrook Health Sciences Centre | Toronto | Ontario | Not Yet Recruiting |
| University Health Network Princess Margaret Cancer Centre | Toronto | Ontario | Not Yet Recruiting |
| CHUM-Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Not Yet Recruiting |
| Montreal Neurological Institute and Hospital James Administration Building | Montreal | Quebec | Not Yet Recruiting |
| CIUSSS NIM - Hôpital du Sacré-Cœur de Montréal | Montreal | Quebec | Not Yet Recruiting |
| Hotel-Dieu de Quebec | Québec | Quebec | Not Yet Recruiting |
| CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Not Yet Recruiting |
| Masaryk Memorial Cancer Institute | Brno | Czechia | Recruiting |
| Universitary hospital Bordeaux France | Bordeaux | France | Recruiting |
| CHU Lyon - Hopital neurologique Pierre Wertheimer | Lyon | France | Recruiting |
| Marseille APHM | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris APHP - Sorbonne | Paris | France | Recruiting |
| Oncopole Claudius Regaud, IUCT-Oncopole | Toulouse | France | Recruiting |
| Universitaskliniken Bonn | Bonn | Germany | Recruiting |
| University Hospital Frankfurt -Senckenberg Institute of Neurooncology | Frankfurt | Germany | Recruiting |
+ 19 more sites — see the full list on the official registry below.
More European Organisation for Research and Treatment of Cancer - EORTC trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06809322 on ClinicalTrials.gov ↗ ← All trials in Belgium