Precision medicine, molecular testing, basket studies, STARTRK-2 – it may sound like technology of the future but it is here today and it might be the answer to slowing or stopping tumor growth for neuroendocrine tumor (NET) patients who have specific gene rearrangements.
What is precision medicine? “Scientists can now detect with unprecedented accuracy the mutations that can lead to cancer. The ability to uncover the interaction of tumor cells has enabled research into the mutations that drive cancer. These discoveries are now the focus of treatments that specifically target cancer cells with these mutations with the hope of slowing or even stopping cancer growth. This is the new era called precision medicine,” explains Pratik Mutani, MD, Chief Medical Officer of Ignyta.
Molecular testing, or Next-Generation Sequencing (NGS), is the process of testing for these types of mutations. With the arrival of NGS, researchers have discovered that tumors with a specific mutation(s) have the potential to respond to a treatment targeted to that mutation. This discovery has led to new designs for clinical trials, more specifically targeting the genetic alterations that drive tumor formation and growth. According to Cure Forward, “Patients who all have a specific tumor mutation, but with varying tumor types, are enrolled into the study and put into individual study arms, or ‘baskets’ by tumor type.”
STARTRK-2, sponsored by Ignyta, Inc., is a basket study of solid tumor types that have NTRK 1/2/3 (Trk A/B/C), ROS1 or ALK gene rearrangements. It is a multicenter, global Phase 2 study of entrectinib (RXDX-1010). Patients will be assigned to different baskets according to tumor type and gene fusion. Entrectinib, an investigational therapy, is designed to target specific causes of certain types of cancer.
How do you know if you qualify? Your doctor can order a no-cost test to see if your cancer has these rearrangements. This test, in most cases, can be performed on a tumor sample that was previously obtained and stored, avoiding the need for a new biopsy.
The study is taking place at 131 locations in the United States; Australia; Belgium; France; Hong Kong; Italy; Japan; Korea, Republic of; the Netherlands; Poland; Singapore; Taiwan; and the United Kingdom. If a potential participant doesn’t live near one of the study locations, Ignyta may be able to open a new location or help to support travel expenses so a participant can travel to one of the current locations.
For more information about the STARTRK-2 basket study and study locations, visit clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/study/NCT02568267?term=Ignyta&rank=1&show_locs=Y#locn, and STARTRK-2 Clinical Trial, https://www.startrktrials.com/, to see if it is right for you.
