DCC-2618 in the Treatment of Advanced Gastrointestinal Stromal Tumors

• Research type

  Research Study

• Full title

  A Phase 3, INterVentional, Double-Blind, Placebo Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapies

• IRAS ID

  240580

• Contact name

  Robin Jones

• Contact email

  robin.jones@rmh.nhs.uk

• Sponsor organisation

  Deciphera Pharmaceuticals, LLC

• Eudract number

  2017-002446-76

• Clinicaltrials.gov Identifier

  na, na

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Summary of Research
  This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of DCC-2618+best supportive care to placebo+best supportive care in patients with advanced GIST who have received treatment with prior anticancer therapies. Prior anticancer therapies must include treatment with imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC-2618 150 mg once daily (QD) or placebo in repeated 28-day cycles.
  Patients will be eligible to receive study drug for up to 2 years or until commercial supply of the drug is available. This may be extended by agreement between the Sponsor and Investigator for patients who exhibit evidence of clinical benefit and tolerability to the drug, and who adhere to the study procedures.

  Summary of Results
  As of May 31, 2019, a total of 129 patients were randomized to and received ripretinib (N = 85) or placebo (N = 44). The patient demographic profile in this study is consistent with the GIST (gastrointestinal stromal tumor) population. Ripretinib demonstrated statistically significant and clinically meaningful improvement in Progression Free Survival. During the double-blind period Ripretinib significantly reduced the risk of disease progression or death by 85% compared to placebo.
  The safety profile of Ripretinib is acceptable relative to the benefit in the context of the treatment of this life-threatening disease. Adverse Events observed with Ripretinib are manageable and the drug appears tolerable. During the double-blind period, the most common Adverse Events (≥ 20%) observed in the Ripretinib arm were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar dysesthesia, and vomiting.
  Overall, Ripretinib demonstrated clinical benefit and a favorable tolerability profile in patients with advanced gastrointestinal

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  18/SC/0139

• Date of REC Opinion

  29 Mar 2018

• REC opinion

  Favourable Opinion