The company expects to enroll approximately 60 to 70 patients with treatment-naive, unresectable pancreatic adenocarcinoma in this single-arm, open-label trial, which will be conducted at multiple investigator sites in the US and abroad.
The primary endpoint of the trial is the objective response rate as measured by RECIST (response evaluation criteria in solid tumors) criteria.
Patients will receive 800 milligrams per meter squared (mg/m2) of gemcitabine and 400mg/m2 of ARQ 501 once weekly, administered as separate intravenous infusions over four-week cycles of therapy. Evaluation of anti-tumor activity will be performed at eight-week intervals until progression is determined.
The company is also developing the compound in head and neck cancer and ovarian cancer.