Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (invictus)

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (invictus)

Gastrointestinal Stromal Tumor

Active, not recruiting

3

Start Date 01/05/2018

Age of Trial (yrs) 6.3

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

DCC-2618-03-001

Deciphera Pharmaceuticals LLC

Clinical Team invictus 781.209.6400 clinicaltrials@deciphera.com

Randomized

Oral

This is a placebo controlled trial. Patients will be randomly assigned to either DCC-2618 or a placebo on a 2:1 ratio. Patients on placebo will be allowed to crossover to DCC-2618 on progression. Progression will be based on CT scans using the RECIST criteria.

Inclusion Criteria:

1. Histologic diagnosis of GIST
2. Patients must have progressed on imatinib, sunitinib, and regorafenib or have documented intolerance to any of these treatments.

Exclusion Criteria:

3. Patients with known KIT or PDGFRA wild-type GIST (eg, SDH deficient or mutant BRAF GIST).