The company has also reported that it has designed a Phase 1/2 clinical trial to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer (CRC) who possess the wild-type form of the KRAS gene.
ARQ 197 is an orally available, small molecule inhibitor of the c-Met receptor tyrosine kinase. The trials will be conducted by Daiichi Sankyo Pharma Development, a division of Daiichi Sankyo, the co-developer of ARQ 197 outside of certain territories in Asia.
The primary aim of this trial is to determine the objective response rate in patients with relapsed or refractory GCT treated with ARQ 197. Where as the secondary objectives include determination of progression free survival, overall survival, and safety and tolerability of ARQ 197 in this population.
Brian Schwartz, chief medical officer at ArQule, said: “The c-Met receptor tyrosine kinase is expressed in human testicular tissue, and analysis of archived testicular tumor specimens at ArQule has confirmed its presence in two thirds of tumor samples. Further, early clinical evidence suggests that inhibition of c-Met with ARQ 197 has anti-cancer activity in this tumor type. These data cumulatively provide a sound rationale for testing ARQ 197 in a Phase 2 clinical setting.”