ALT GIST (EORTC 1321)

• Research type

  Research Study

• Full title

  A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST).

• IRAS ID

  196674

• Contact name

  Charlotte Benson

• Contact email

  charlotte.benson@rmh.nhs.uk

• Sponsor organisation

  European Organisation for Research and Treatment of Cancer

• Eudract number

  2015-001298-42

• Clinicaltrials.gov Identifier

  NCT02365441

• Duration of Study in the UK

  5 years, 4 months, 1 days

• Research summary

  This is a prospective, randomised, open label phase II trial, stratified by participating site, previous adjuvant therapy (prior vs none), and previous imatinib for metastatic disease for less than 21 days.
  The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety to warrant further evaluation as a first line treatment for metastatic GIST.
  The target population is adults with histologically confirmed, measurable metastatic GIST, who have received no prior treatment for metastatic disease. Patients who are currently taking, and have had up to 21 days of uninterrupted treatmentwith 400mg daily of imatinib are eligible to participate in this study.
  Patients will be randomised to receive either:
  Arm A – imatinib 400mg orally daily continuously (control arm);
  or
  Arm B – alternating 28‐day periods of imatinib 400mg orally daily for 21 to 25 days followed by a washout (drug free) period of 3 to 7 days, then regorafenib 160mg orally daily for 3 weeks followedby a 7 day washout (drug free) period.
  Treatment will continue until disease progression or prohibitive adverse events as detailed in the protocol.
  Following endpoints are:
   Progression free survival (Primary)
   Objective tumour response rate
   Clinical benefit rate
   Complete response rate
   Time‐to‐treatment failure
   Safety/Toxicity/Tolerability
   Overall Survival

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  16/NE/0112

• Date of REC Opinion

  22 Apr 2016

• REC opinion

  Favourable Opinion