TRIAL DETAIL

A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)

Drug:
Trial Name:
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 02/11/2019
Age of Trial (yrs) .6
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
DCC-2618-03-002
Sponsor:
Deciphera Pharmaceuticals LLC
Patient Contact:
Clinical Team 785-830-2100 clinicaltrials@deciphera.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria:

Patients ≥ 18 years of age at the time of informed consent.
Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
Patients must have progressed on imatinib or have documented intolerance to imatinib.
Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.
Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
The patient is capable of understanding and complying with the protocol and has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed.

Exclusion Criteria:

Treatment with any other line of therapy in addition to imatinib for advanced 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
Sandy Springs
GA
30342
USA
Jacksonville
FL
32224
USA
Rochester
MN
55905
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
Charlottesville
VA
22903
USA
Toledo
OH
43606
USA
Dallas
TX
75246
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
Denver
CO
80218
USA
1475 Northwest 12th Ave
Miami
FL
33136
USA
Iowa City
IA
52242
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
300 W. 10th Ave.
Columbus
OH
43210
USA
Oklahoma City
OK
73104
USA
Melbourne
Australia
610 University Ave
Toronto
ON
M5G 2M9
Canada
Singapore
Singapore
Miami
FL
33176
USA
Portland
OR
97239
USA
1365C Clifton Road
Atlanta
GA
30322
USA
5841 S. Maryland Ave
Chicago
IL
60637
USA
535 Barnhill Drive
Indianapolis
IN
46202
USA
111 East 210th St.
Bronx
NY
10467
USA
1275 York Ave
New York
NY
10065
USA
Durham
NC
27710
USA
2220 Pierce Ave.
Nashville
TN
37232
USA
401 College St.
Richmond
VA
23298
USA
8701 Watertown Plank Rd.
Milwaukee
WI
53226
USA
Barker Street
Randwick
New South Wales
2031
Australia
199 Ipswich Road
Woolloongabba
Queensland
4102
Australia
Ottawa
Ontario
K1H 8L6
Canada
Hamilton
Ontario
L8V 5C2
Canada
via Giacomo
Milan
20133
Italy
Oslo
0424
Norway
Warsaw
02-781
Poland
Carrer de Sant Antoni Maria Clare, 167
Barcelona
08025
Spain
Barcelona
Spain
197 Fulham Rd.
London
SW3 6JJ
UK
Albury
NSW
Australia
Lake Success
NY
11042
USA
Louisville
KY
40241
USA
New Haven
CT
06511
USA
Los Angeles
CA
90024
USA
La Jolla
CA
92037
USA
520 South Road
Kurrulta Park
South Australia
5037
Australia
Linkou
Taoyuan County
Taiwan