IRB #

IRB00007264

Title

Phase II Study of crenolanib (CP-868,596), a Selective and Potent Inhibitor of PDGFR, for the Treatment of Patients with Advanced Gastrointestinal Stromal Tumors with the D842-related mutations or deletions, including the D842V Mutation in the PDGFRA Gene

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is to find out what effects, good or bad, the study drug – crenolanib (CP-868,596) – has on subjects with advanced Gastrointestinal Stromal Tumors (GIST) with the D842-related mutations or deletions, including the D842V mutation in the PDGFRA (Platelet Derived Growth Factor Receptor) gene.

Medical Condition(s)

GIST

Eligibility Criteria

* Subjects must be 18 years or older
* Subjects must have been diagnosed with GIST with a D842-related mutation or deletion on the PDGFRA gene
* Subjects must have received prior chemotherapy or radiation therapy

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Subjects will be given an oral drug twice a day and followed closely for side effects. Subjects will return for weekly clinic visits for the first month of treatment, then return for clinic visits every two weeks during the second month. Subjects will then return to clinic once every two months (for two visits), then once every three months until the end of their study participation.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

AROG Pharmaceuticals, LLC

Recruitment End

Compensation Provided

No