臨床研究等提出・公開システム

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

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Nunomura Masaki

PPD-SNBL K.K.

St Luke's Tower 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan

Masaki.Nunomura@ppd.com

Nunomura Masaki

PPD-SNBL K.K.

St Luke's Tower 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan

+81-80-5933-4186

Masaki.Nunomura@ppd.com

Not Recruiting

May. 22, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Safety Lead-in Period
- Be at least 18 years of age.
- Have a histologically proven Grade 2 or 3 IDH mutant glioma.
- Subjects must have disease that has recurred or progressed following radiation and/or chemotherapy or that has not responded to this therapy.
- Have a documented IDH1 or IDH2 gene-mutation based on local assessment.
- MRI-evaluable disease as assessed by the site radiologist.
- Have a KPS >=70.
- Have expected survival of at least 3 months.

Randomization Period
- Be at least 18 years of age.
- 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 (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
- 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 BIRC.
- Have a Karnofsky Performance Scale (KPS) score of >=80%.

Safety Lead-in Period
- Subjects who received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration or who received an investigational agent <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period >=5 half-lives of the investigational agent has elapsed.
- Have had prior treatment with bevacizumab (Avastin).

Randomization Period
- 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, laser ablation, etc.
- Have features assessed as high-risk 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).

Both

Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

- Vorasidenib
Vorasidenib oral film-coated tablets
Other Name: AG-881
- Matching Placebo
Matching Placebo oral tablets

Imaging assessment of Progression-Free Survival (PFS) by blinded independent review committee(BIRC)

+81-82-257-5596

Yes

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