AROG ARO-012 for GIST with D842V mutation in the PDGFRA gene (Gastrointestinal Stromal Tumors) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug crenolanib will work versus placebo (sugar pill) in patients with GIST.

What is the Condition Being Studied?

Advanced GIST tumors (gastrointestinal stromal tumors)

Who Can Participate in the Study?

Adults with:
- Advanced GIST with a specific genetic abnormalilty (D842V mutation in the PDGFRA gene)
- Disease progression within 6 months of entering the study.
- No other therapy within 3 weeks of entering the study

Age Group

What is Involved?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get crenolanib or placebo (sugar pills) pills that are taken by mouth 3 times a day as long as you are not getting worse.
- Return to Duke for study visits once a month.

Study Details

Full Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00075745
NCT: NCT02847429
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center