Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Inclusion Criteria

• •1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
• •2. 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
• •3. Subjects (male or female) ≥ 18 years of age
• •4. Female subjects with reproductive potential must have negative serum or urine pregnancy test
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2