TRIAL DETAIL

Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Drug:
Trial Name:
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 08/01/2016
Age of Trial (yrs) 3.1
Treatment Phase:
Gleevec-resistant
Drug Category:
D842V
Strategy:
Block PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
ARO-012
Sponsor:
Arog Pharmaceuticals, Inc.
Patient Contact:
Bradley Chiga 214-593-0550 bchiga@arogpharma.com Information Contact info.012@davacro.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Purpose
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care

Inclusion Criteria:

Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing

Measurable disease as per modified RECIST 1.1

• A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization

Trial Links

Trial Results

Drug Information

AROG website - produce pipeline
 
Phase 1 study of CP-868,596 an oral, highly specific PDGFR inhibitor.
 
Phase Ib study of CP-868,596, a PDGFR inhibitor, combined with docetaxel with or without axitinib, a VEGFR inhibitor
 
NCI Drug Thesaurus
 
2011 AACR abstract - CP-868,596, a highly potent PDGFR inhibitor, inhibits phosphorylation of the imatinib-resistant PDGFRA D842V activating mutation associated with advanced GIST
 
D842V gets its moment in the spotlight
 
Phase I poster from 2011 AACR (PDF)
 
CTOS 2011 Poster - EFFICACY OF CRENOLANIB AGAINST THE PDGFRA ACTIVATING MUTATION, D842V, ASSOCIATED WITH GASTROINTESTINAL STROMAL TUMORS (PDF - 529 KB)
 
PRELIMINARY REPORT OF CRENOLANIB IN THE TREATMENT OF ADVANCED PLATELET DERIVED GROWTH FACTOR A (PDGFRA) D842V MUTANT GASTROINTESTINAL STROMAL TUMOR (GIST) (PDF 613 KB)
 
Crenolanib Inhibits the Drug-Resistant PDGFRA D842V Mutation Associated with Imatinib-resistant Gastrointestinal Stromal Tumors
 
FDA grants fast track designation for crenolanib fof advanced GIST with a D842V mutation in PDGFRA
 

Trial Sites

Name
Address
City
State
Zip
Country
2811 Wilshire Blvd
Santa Monica
CA
90403
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
Durham
NC
27710
USA
1475 Northwest 12th Ave
Miami
FL
33136
USA
Baltimore
MD
21231
USA
229 Cours Argonne
Bordeaux
Gironde
33076
France
Lille
Nord
59020
France
28 rue Laennec
Lyon
Rhone
69008
France
Marseille
13000
France
Montpellier
France
Reimes
France
Villejuif
Val de Narne
94805
France
Schwanebecker Chaussee
Berlin
Germany
Mannheim
68167
Germany
Munich
D-81377
Germany
via Giacomo
Milan
20133
Italy
Oslo
N-0310
Norway
Warsaw
02-781
Poland
119-129
Barcelona
08035
Spain
Madrid
Spain
Cambridge
CB2 OQQ
UK
197 Fulham Rd.
London
SW3 6JJ
UK
Bologna
Italy
Rome
Italy
Turin
Italy
Sevilla
Spain
Valencia
Spain
Sheffield
UK