TRIAL DETAIL

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

Drug:
Trial Name:
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (invictus)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Activ, not recruiting
Phase:
3
Start Date 01/05/2018
Age of Trial (yrs) 1.2
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
DCC-2618-03-001
Sponsor:
Deciphera Pharmaceuticals LLC
Patient Contact:
Clinical Team invictus 781.209.6400 clinicaltrials@deciphera.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
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).

Trial Links

 
 

Trial Results

Drug Information

4/1/2009 AACR #3733- Small molecule modulators of KIT kinase for treatment of gastrointestinal stromal tumors (GIST). Inhibitors of juxtamembrane domain, D816V, T670I and V654A mutant forms
 
6/1/2010 ASCO - In vitro activity of novel KIT/PDGFRA switch pocket kinase inhibitors against mutations associated with drug-resistant GI stromal tumors.
 
Deciphera pipeline description of DCC-2618
 
Deciphersa Switch Pocket Type II Inhibitors graphics
 
4/3/2017 Business Wire news story: Translational Research Results Confirm The Broad Activity of DCC-2618 in GIST Patients With Difficult to Treat Drug Resistant KIT Mutations
 
12/1/2016 EEORTC-NIH-AACR meeting abstract
 

Trial Sites

Name
Address
City
State
Zip
Country
10460 N. 92nd St.
Scottsdale
AZ
85258
USA
Palo Alto
CA
94304
USA
Portland
OR
97239
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
Atlanta
GA
30341
USA
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
1441 Eastlake Avenue
Los Angeles
CA
90033
USA
Jacksonville
FL
32224
USA
5841 S. Maryland Ave
Chicago
IL
60637
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
Minneapolis
MN
55455
USA
Rochester
MN
55905
USA
1275 York Ave
New York
NY
10065
USA
Herestraat 49
Leuven
Belgium
11560 University Avenue
Edmonton
Alberta
T6G 1Z2
Canada
610 University Ave
Toronto
ON
M5G 2M9
Canada
Helsinki
FIN-00029
Finland
28 rue Laennec
Lyon
Rhone
69008
France
229 Cours Argonne
Bordeaux
Gironde
33076
France
Villejuif
Val de Narne
94805
France
Hufelandstr. 55
Essen
45122
Germany
Mannheim
68167
Germany
via Giacomo
Milan
20133
Italy
Leiden
Netherlands
Singapore
Singapore
119-129
Barcelona
08035
Spain
Sevilla
Spain
197 Fulham Rd.
London
SW3 6JJ
UK
New York
NY
10027
USA
Melbourne
Australia
Brandenburg
Germany
Rome
Italy
Warsaw
Poland
Sheffield
UK