Acronym:
INTRIGUE
ACTRN/NCT /ethics:
NCT03673501
Scientific title:
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Summary of trial and patient characteristics
| Cancer Type | Bowel and colon | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase III | Tumour Stream | Gastrointestinal Stromal Tumors |
| Age Range | 18 years and older | Cancer Stage | Locally Recurrent or Locally Advanced |
| Sex | Both | Anticipated Start Date | 2019-02-11 |
| Molecular Target | Anticipated End Date | 2022-03-01 | |
| Cancer Type | Bowel and colon |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Gastrointestinal Stromal Tumors |
| Cancer Stage | Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2019-02-11 |
| Anticipated End Date | 2022-03-01 |
Trial Summary
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
Lay Summary
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Sponsor / Cooperative group
Deciphera
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Ashford Cancer Centre Research | Sue Yeend | syeend@adelaidecancercentre.com.au | 08 8292 2240 | Dr Sarwan Bishnoi | Recruiting |