Ignyta Announces Initiation Of STARTRK-1 Global Phase I/II Clinical Trial Of RXDX-101

Ignyta, Inc.

, an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations. “We are excited to be able to expand the clinical dosing of this product candidate to patients at leading cancer centers in the U.S., Europe and Asia,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “The initiation of the STARTRK-1 trial builds on the momentum of our presentation of interim data from the ongoing RXDX-101 Phase I clinical trial at the ASCO annual meeting, where we reported partial responses in patients with each of TrkA, ROS1 and ALK alterations, as well as in three different tumor types.” “The emergence of cancer therapies targeted to specific genetic alterations is an important advance in the treatment of solid tumors,” said Alexander Drilon, M.D., a medical oncologist in the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and a principal investigator in the STARTRK-1 trial. “This trial will help elucidate the clinical effects of RXDX-101, which inhibits pan-Trk, ROS-1 and ALK proteins, and allow us to better understand the drug's potential to help these very sick patients.” The trial will involve multiple clinical sites in the U.S., Europe, and Asia. Sites that Ignyta anticipates will dose patients in the Phase I portion of the trial include Chao Family Comprehensive Cancer Center at UC Irvine, Lombardi Comprehensive Cancer Center at Georgetown, Massachusetts General Hospital/Dana Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Sarah Cannon Research Institute, and the University of Texas M.D. Anderson Cancer Center.