Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Gastrointestinal Stromal Tumor

Active, not recruiting

3

Start Date 08/01/2016

Age of Trial (yrs) 7.2

Gleevec-resistant

D842V

Block PDGFRA

Specifically GIST and only GIST

ARO-012

Arog Pharmaceuticals, Inc.

Bradley Chiga 214-593-0550 bchiga@arogpharma.com Information Contact info.012@davacro.com

Randomized

Oral

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