Deciphera Pharmaceuticals DCC-2618-03-002 INTRIGUE
Research type
Research Study
Full title
A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib
IRAS ID
259033
Contact name
Robin Lewis Jones
Contact email
Sponsor organisation
Deciphera Pharmaceuticals
Eudract number
2018-001803-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
125279, IND
Duration of Study in the UK
2 years, 10 months, 15 days
Research summary
Gastrointestinal Stromal Tumours represent the most common form of sarcoma, a relatively rare subset of cancers arising from mesenchymal cells in the body. Adult GIST occurs with an incidence rate of ~3,000-6,000 new cases per year in the US, generally presents around age 50-70, and occurs in men and women at similar rates. For metastatic or unresectable GIST, which is present in about half of patients at diagnosis, radiotherapy and traditional chemotherapy are not effective.
This study involves research of a potential new oral inhibitor, DCC-2618, of KIT kinase and PDGFRA kinase. It comprehensively and potently inhibits a broad range of primary and secondary mutants of KIT and primary initiating mutations of PDGFRA.
Participants will be randomised 1:1 to DCC-2618 versus sunitinib in one of the two treatment arms:
1. DCC-2618 150 mg tablets for oral administration once daily (QD) continuous 42 day cycles;
2. Sunitinib 50 mg for oral administration QD, 4 weeks on, 2 weeks off, 42 days cycles.The study consists of a screening period, randomisation, up to two years treatment and safety/overall survival and disease progression follow-up. The participant will remain in the study for up to 24 months.
It is expected that about 358 patients will participate in approximately 115 sites around the world. In the UK it is expected that the study will take place in 05 sites.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0148
Date of REC Opinion
1 Apr 2019
REC opinion
Further Information Favourable Opinion