Avapritinib vs Regorafenib in patients with GIST

• Research type

  Research Study

• Full title

  An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

• IRAS ID

  240191

• Contact name

  Anthony Boral

• Contact email

  aboral@blueprintmedicines.com

• Sponsor organisation

  Blueprint Medicines Corporation

• Eudract number

  2017-003497-14

• Clinicaltrials.gov Identifier

  NCT03465722

• Clinicaltrials.gov Identifier

  125379, IND number

• Duration of Study in the UK

  2 years, 5 months, 30 days

• Research summary

  Summary of Research
  Patients in this study have Gastrointestinal Stromal Tumours (GIST), a type of tumour found most often in the wall of the stomach. This is normally treated by surgery followed by treatment with a drug called imatinib which works by blocking a chemical that the cancer needs so it can grow. However if the GIST has grown, imatinib may no longer work, so this study is designed to treat those patients who have advanced GIST which cannot be removed by surgery, or their cancer has spread, and who can no longer take imatinib. These patients may have received imatinib and up to two other treatments which are no longer working. The purpose of this study is to look at how well the study drug, avapritinib, works and if it is safe compared to a drug called regorafenib which is licensed to treat people with GIST when imatinib has not worked. The study will look at the survival time of participants before the cancer becomes worse or spreads, and how the tumour responds to study treatment. The medical need is high for new innovative anti-cancer therapies that are safe and work well, including therapies for patients with GIST. The participants will continue to receive treatment with the trial drug until their disease worsens or they decide to leave the study. Participants whose disease worsens during the study while taking regorafenib will be offered the opportunity to take avapritinib at the study doctor’s discretion. The information collected from this study may enable doctors to make better decisions about which treatments to use for this type of advanced GIST and might improve the future treatment of patients with GIST.

  Summary of Results
  No Lay summary of study results is planned to be shared with the patients, since it is available for the public on:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMksW8zLQjzhDJMDSluizpiKroSDcx-2Bi6X00-2FA-2BmtR4dFEItvPdAET2R2NoxArpLzaqPg5_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKK5vfweiqd7h25VUWjQiraH-2FqSBuev4G8xYYrBDb6mDH-2B4qebZiSchfGUmv5cZZ8FBjlsmAi0xzfSektRdM6C9djqkt2tUhOUuHFYEwuFAyOZelr-2FyRbLz-2F5oOt6yZPdPsqokAV-2Fg06J-2Fe5YR5odbJNOWeiWEm7sxFYxnGg-2BS8IA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca9564247e1a84692c93808da94d810ed%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637985952960736535%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lbQ%2BTFu0q8%2Bx8S60yCegXwEfUokrIOo1CwdDIy0Zido%3D&reserved=0

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  18/LO/0671

• Date of REC Opinion

  23 Apr 2018

• REC opinion

  Favourable Opinion