Study Design

Please see the INDIGO Study Record for the full set of inclusion and exclusion criteria.


Unblinding and Crossover5

Once radiographic progression of disease (PD) is confirmed, the subject and site staff will be unblinded to treatment assignment. Subjects who are determined to be receiving placebo upon unblinding after centrally confirmed radiographic PD, and who are not in need of immediate chemotherapy or radiotherapy, will have the option to cross over to receive vorasidenib, provided certain eligibility criteria are met.


How to Enroll Patients

To find current study sites and to learn how to enroll your patient, please see the INDIGO Study Site Locator.

Disclaimer

The effectiveness and safety of vorasidenib have not been established. There is no guarantee that vorasidenib will receive health authority approval or become commercially available in any country for the use being investigated.

References

  1. Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 Mutations in Gliomas. N Engl J Med. 2009; 360(8):765-773.
  2. Cancer Genome Atlas Research Network, Brat DJ, Verhaak RG, et al. Comprehensive, Integrative Genomic Analysis of Diffuse Lower-Grade Gliomas. N Engl J Med. 2015; 372(26):2481-2498.
  3. NCT02481154, Mellinghoff et al. Society of Neuro-oncology Annual Meeting 2018.
  4. NCT03343197, Mellinghoff et al. American Society of Clinical Oncology Annual Meeting 2019.
  5. Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) – https://clinicaltrials.gov/ct2/show/NCT04164901