TRIAL DETAIL

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Drug:
Trial Name:
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 03/26/2018
Age of Trial (yrs) 1.5
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-285-1303
Sponsor:
Blueprint Medicines Corporation
Patient Contact:
Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Brief Summary:
This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

nclusion Criteria:

Patients who are ≥ 18 years of age.
Patients who have histologically confirmed metastatic or unresectable GIST.
Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.

Exclusion Criteria (Partial):

Patients who have received prior treatment with avapritinib or regorafenib.
Patients who have received more than 3 different prior TKI treatment regimens.
Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild type.

Trial Links

 
 

Trial Results

Drug Information

Avapritinib on GISTTrials website
 
Regorafenib on GISTTrials website
 

Trial Sites

Name
Address
City
State
Zip
Country
1475 Northwest 12th Ave
Miami
FL
33136
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
1275 York Ave
New York
NY
10065
USA
Columbus
OH
43210
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
28 rue Laennec
Lyon
Rhone
69008
France
Seoul
Songpa-gu
138-736
Republic of Korea
Phoenix
AZ
85054
USA
Jacksonville
FL
32224
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
Villejuif
Val de Narne
94805
France
229 Cours Argonne
Bordeaux
Gironde
33076
France
197 Fulham Rd.
London
SW3 6JJ
UK
Lund
SE-221 85
Sweden
Clayton
Australia
12902 Magnolia Dr.
Tampa
FL
33612
USA
Rochester
MN
55905
USA
Pittsburgh
PA
15232
USA
Nashville
TN
37203
USA
101 DAEHAK-RO
Seoul
110-774
Republic of Korea
Seoul
Republic of Korea
Spokane
WA
99216
USA
Toronto
ON
M5G 1L7
Canada
1665 N. Ursula St.
Aurora
CO
80045
USA
675 North St. Clair
Chicago
IL
60611
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
Durham
NC
27710
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
2000 Circle of Hope
Salt Lake City
UT
84103
USA
Seattle
WA
98104
USA
8701 Watertown Plank Rd.
Milwaukee
WI
53226
USA
Yamba Drive
Garran
Australian Capital Territory
2605
Australia
Brussels
Belgium
Herestraat 49
Leuven
Belgium
11560 University Avenue
Edmonton
Alberta
T6G 1Z2
Canada
Lille
59020
France
Marseilles
13000
France
Marseille
13000
France
Nantes
France
Pieskower Straße 33
Bad Saarow
15526
Germany
Schwanebecker Chaussee
Berlin
Germany
Hufelandstr. 55
Essen
45122
Germany
Bologna
Italy
via Giacomo
Milan
20133
Italy
Via del Vespro, 129
Palermo
90127
Italy
Rome
Italy
Seoul
Republic of Korea
Warsaw
Poland
Singapore
Singapore
Carrer de Sant Antoni Maria Clare, 167
Barcelona
08025
Spain
Barcelona
Spain
119-129
Barcelona
08035
Spain
Madrid
28046
Spain
Sevilla
Spain
Glasgow
G12 0YN
UK
Manchester
M20 4BX
UK
Sheffield
UK
Flinders Drive
Bedford Park
South Australia
5042
Australia
Vienna
A1090
Austria
Pécs
Hungary
Santa Monica
CA
90404
USA
Washington
DC
20010
USA
Atlanta
GA
30341
USA
Waco
TX
76712
USA
Montreal
Quebec
Canada
Prague
Czechia
Dresden
Germany
Frankfurt
Germany
Lubeck
Germany
Mannheim
Germany
Budapest
Hungary
Budapest
Hungary
Debrecen
Hungary
Firenze
Italy
Milano
Italy
Suwon
Republic of Korea
Olsztyn
Poland
Wroclaw
Poland
Zaragosa
Spain
London
UK
Dallas
TX
75246
USA