Virginia Cancer Specialists would like to inform you, that our practice is participating in a Phase 2 basket study of entrectinib (also known as RXDX-101), a novel inhibitor of the receptor tyrosine kinases TrkA (encoded by the gene NTRK1), TrkB (encoded by the gene NTRK2), TrkC (encoded by the gene NTRK3), ROS1 (encoded by the gene ROS1), and anaplastic lymphoma kinase (ALK; encoded by the gene ALK). This study is called STARTRK-2 and is sponsored by Ignyta, a San Diego-based biotechnology company.
The study is open for patients with any locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement.
If you or your patient has not had molecular testing performed, Ignyta’s CAP-accredited, CLIA-certified laboratory can perform the testing at no cost to patients to determine STARTRK-2 eligibility. Ignyta will also accept molecular testing results from local laboratories to determine STARTRK-2 eligibility, as long as the testing was performed on a nucleic acid-based diagnostic method, e.g., FoundationOne NGS test.
The following are key points regarding the study and entrectinib:
In Phase 1 trials, this once-daily, oral medication has demonstrated an overall response rate of 72% among TKI-naïve patients with NTRK1, NTRK2, NTRK3, ROS1, or ALK gene rearrangements who were treated at a therapeutic dose level (Siena et al, ESMO 2015).
STARTRK-2 is currently enrolling patients with gene rearrangements in a wide range of solid tumors, including NSCLC, numerous sarcomas, various head, neck, and brain cancers as well as gastrointestinal cancers.
Patients with asymptomatic or previously treated and controlled brain metastases are eligible.
Prior therapies are allowed, with the exception of TKIs against the target genes.
Ignyta can assist with all patient travel related expenses.
For additional information, please refer to www.STARTRKtrials.com or ClinicalTrials.gov identifier NCT02568267. For all available trials offered through the VCS Research Institute, please visit /vcs-research-institute-overview/
