Etude : INDIGO / AG881-C-004



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : INDIGO / AG881-C-004

Situation thérapeutique :

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 07/01/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Spécialité : Oeil, cerveau et autres parties du système nerveux central
Localisation : C71 - Tumeur maligne de l'encéphale
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 366 participants are planned to be randomized 1:1 to receive orally administered AG-881 40 mg QD or placebo.

STUDY ARMS:
- Experimental: AG-881
AG-881 40 mg, continuous daily dosing.

- Placebo Comparator: Matching Placebo
Matching placebo 40 mg, continuous daily dosing. Participants who experience radiographic disease progression and who were receiving placebo will have the option to cross-over to AG-881, provided certain criteria are met.

MAIN OBJECTIVE:
To demonstrate the efficacy of AG-881 based on radiographic progression-free survival (PFS) per blinded independent review committee (BIRC) compared with placebo in subjects with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation.

SECONDARY OBJECTIVES:
• To evaluate safety and tolerability of AG-881 compared with placebo.
• To evaluate the efficacy of AG-881 based on tumor growth rate (TGR) as assessed by volume per the BIRC compared with placebo.
• To evaluate time to next intervention.
• To compare the efficacy of AG-881 with placebo based on objective response rate (ORR), time to response, and duration of response, with response assessed per the BIRC and the Investigator.
• To evaluate overall survival (OS).
• To evaluate health-related quality of life (HRQoL) with AG-881 compared with placebo as assessed by the Functional Assessment of Cancer Therapy – Brain questionnaire.
• To investigate PFS per the Investigator assessment.
• To evaluate the pharmacokinetics (PK) of AG-881 in plasma.

Phase : III

Stade : Localisé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : • Be at least 12 years of age and weigh at least 40 kg.
• Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
• Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year and not more than 5 years before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy.
• Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory.
• Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the blinded independent review committee (BIRC)
• Have a Karnofsky Performance Scale (KPS) score (for subjects ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for subjects <16 years of age) of ≥80%.

Critères de non-inclusion : • Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, etc.
• Have high-risk features as assessed by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04164901
Promoteur :
AGIOS PHARMACEUTICALS
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Enora VAULEON

TEC / ARC / IDE :
Camille GOMBERT
camille.gombert@
chru-lille.fr
03.20.44.59.62 poste 30444

Statut de l'essai : CLOS

MAJ : 07/01/2022