The primary objective of the microphthalmia transcription factor tumors trial is to determine the overall response rate in patients treated with the drug, ARQ 197. Secondary objectives include the evaluation of progression-free survival time, as well as six-month and one-year overall survival in these patients.
The primary objective of the pancreatic adenocarcinoma trial is to evaluate and compare progression-free survival in the two groups of patients. Secondary objectives include the evaluation of overall response rate and one-year overall survival rates in both groups.
Stephen Hill, president and CEO of ArQule, said: “These trials mark the first in a series of studies with ARQ 197 that we expect to initiate in the coming months. They will test therapeutic approaches that are based on the multiple roles of c-Met as a driver of cancer development.
“Our second trial with ARQ 197 targets treatment-naive patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma. Given the abnormal level of c-Met over-expression in pancreatic tumor tissue samples, the demonstrated activity of ARQ 197 in animal models of human pancreatic cancer, and the activity and safety profile of this compound seen in Phase I testing, we believe this disease represents another promising indication for ARQ 197.”