TRIAL DETAIL

A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

Drug:
Trial Name:
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1
Start Date 10/30/2015
Age of Trial (yrs) 3.9
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
DCC-2618-01-001
Sponsor:
Deciphera Pharmaceuticals
Patient Contact:
Jama Pitman jpitman@deciphera.com clinicaltrials@deciphera.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an expansion phase.

Inclusion Criteria: Patients with solid tumor or hematologic malignancy must have a histologically confirmed, locally advanced malignancy refractory or intolerant to standard therapies and/or have no alternative effective therapy available, with the following exceptions: GIST patients must have progressed at least on imatinib.

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
1505 Holcombe Blvd.
Houston
TX
77030
USA
610 University Ave
Toronto
ON
M5G 2M9
Canada
450 Brookline Ave
Boston
MA
02215-5450
USA
10460 N. 92nd St.
Scottsdale
AZ
85258
USA
875 Blake Wilbur Drive
Palo Alto
CA
94304
USA
1475 Northwest 12th Ave
Miami
FL
33136
USA
Portland
OR
97239
USA
1275 York Ave
New York
NY
10065
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
2000 Circle of Hope
Salt Lake City
UT
84103
USA
197 Fulham Rd.
London
SW3 6JJ
UK
Jacksonville
FL
32224
USA
Leiden
2333
Netherlands