TRIAL DETAIL

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

Drug:
Trial Name:
(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Active, not recruiting
Phase:
1
Start Date 08/01/2015
Age of Trial (yrs) 6.3
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + D842V inhibitor
Strategy:
Block KIT/PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
BLU-285-1101 NAVIGATOR
Sponsor:
Blueprint Medicines Corporation
Patient Contact:
Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of BLU-285, administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).

Trial Links

 
 
 
 
 
 
 
 

Trial Results

 
 
 
 
 

Drug Information

Blueprint programs
 
BLU-285 in GIST at AACR 2015
 
AACR 2015 Abstract #791: BLU-285, the first selective inhibitor of PDGFRα D842V and KIT Exon 17 mutants
 
LRG Story: Update on Blueprint Medicines Clinical Trial for BLU-285
 
2017 AACR BLU-285 Presentation by Blueprint
 
2017 AACR KU Leuven Abstract (
 
2016 EEORTC-NIH-AACR Munich Heinrich presentation
 
2019 ASCO - Clinical activity of avapritinib in 4L or greater GIST including PDGFRA exon 18 and D842V
 
Avapritinib prescribing information
 
AYVAKIT.com website, resources for patients, support program, etc.
 
Summary of Risk Management Plan for AYVAKYT (Avapritinib) - An EMA summary (PDF)
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
Portland
OR
97239
USA
Herestraat 49
Leuven
Belgium
's-Gravendijkwal 230
Rotterdam
3015
Netherlands
Hufelandstr. 55
Essen
45122
Germany
28 rue Laennec
Lyon
Rhone
69373
France
197 Fulham Rd.
London
SW3 6JJ
UK
Villejuif
Val de Narne
94805
France
1475 Northwest 12th Ave
Miami
FL
33136
USA
1275 York Ave
New York
NY
10065
USA
via Giacomo
Milan
20133
Italy
Seoul
Songpa-gu
138-736
Republic of Korea
Warsaw
02-781
Poland
119-129
Barcelona
08035
Spain
1505 Holcombe Blvd.
Houston
TX
77030
USA
2811 Wilshire Blvd
Santa Monica
CA
90403
USA
Scottsdale
AZ
85258
USA
Atlanta
GA
30256
USA