On December 9, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported the initiation of STARTRK-NG, a new pediatric Phase 1/1b clinical trial of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors that harbor activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK (Press release, Ignyta, DEC 9, 2015, View Source [SID:1234508511]). Schedule your 30 min Free 1stOncology Demo! STARTRK-NG (which stands for "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases – Next Generation") is a multicenter, open label, dose-escalation and expansion study designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of entrectinib in children and adolescents with recurrent or refractory extracranial solid tumors or primary central nervous system (CNS) tumors, including indications such as neuroblastoma.
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"We are excited to expand the clinical development program for entrectinib with this first clinical study in pediatric patients," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "There is abundant scientific evidence suggesting that inhibition of oncodrivers such as Trk and ALK could be effective in many cancers in children and adolescents. Because entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, as well as a potent inhibitor of ALK, and given entrectinib’s clinically demonstrated activity in the central nervous system, we look forward to conducting this study of entrectinib for the benefit of these patients."
The clinical sites participating in the STARTRK-NG trial are the four Alex’s Lemonade Stand Foundation for Childhood Cancer Centers of Excellence:
The Children’s Hospital of Philadelphia,
Dana-Farber/Boston Children’s Cancer Hospital,
Texas Children’s Cancer Center, and
University of California, San Francisco.
About Entrectinib
Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/ TrkB/TrkC), ROS1 or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against CNS metastases. In addition to the STARTRK-NG trial, this product candidate is in a Phase 2 clinical trial called STARTRK-2. The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.