Clovis Oncology, based in Boulder, Colo., has reached the target enrollment of 360 patients in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer.
LEAP is an international, randomized, controlled, pivotal trial designed to demonstrate that CO-101, a lipid-conjugated form of the anti-canc3er drug gemcitabine, improves overall survival versus gemcitabine in hENT1-low metastatic pancreatic cancer patients. LEAP is the first study to utilize a companion diagnostic in metastatic pancreatic cancer and enrollment required collection of metastasis biopsies prior to randomization, necessary to allow comprehensive assessment of tumor hENT1 expression as a modifier of treatment outcome.
“This is the first registration study that attempts to bring personalized medicine to patients with pancreatic cancer, and our team and our investigators did a superb job in completing enrollment in only 19 months,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “If successful, this trial has the potential to be practice-changing in the management and treatment of metastatic pancreatic cancer, a disease for which only limited options are available today.”
The study is being conducted at 99 centers in 15 countries. Top-line overall survival data from LEAP are expected in the fourth quarter of 2012. If the trial is successful, Clovis intends to file for approval in the U.S. and Europe by mid-2013. CO-101 has an orphan drug designation in both the U.S. and Europe for the treatment of pancreatic cancer.