Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene

Inclusion Criteria

• •Male or female, of any racial or ethnic group
• •Age 18 years or older
• •Life expectancy of greater than 12 weeks
• •Patient able and willing to provide informed consent
• •Normal liver function, defined as AST and ALT ≤2.5x ULN, and Total Bilirubin ≤ 2x ULN.
• •Total creatinine ≤ 1.5x ULN
• •ECOG Performance Status 0 - 2 (Appendix II)
• •Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene
• •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
• •Patients must have recovered from any prior therapy and completed the minimum of, either 5 half-lives of prior therapy or 2 weeks must have elapsed since prior treatment