The Phase 2 STARTRK-2 clinical trial is recruiting patients with locally advanced or metastatic solid tumors harboring specific gene fusions. This study seeks to show that entrectinib has potent, targeted activity with an acceptable safety profile.
STARTRK-2 is an open-label, global, Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with locally advanced or metastatic solid tumors that harbor NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusions. The "basket" design means that patient outcomes will be analyzed by "basket", according to tumor type and gene fusion.
In Phase 1 studies, 119 patients have been treated with the recommended dose of entrectinib. Among 24 patients whose tumors tested positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusions,
entrectinib showed an overall response rate of:
Targeted therapy with entrectinib
Entrectinib is a TKI (tyrosine kinase inhibitor) developed to target tumors carrying NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusions. It is believed to inhibit the specific members of the receptor tyrosine kinase family encoded by these genes.
Molecular testing for STARTRK-2 trial
See if your patients may qualify by having our CAP accredited diagnostic lab evaluate the genetic profile of tumor biopsy samples. The presence of a rearrangement of interest is determined by next-generation sequencing at no-cost to your practice.
See if your patients may be eligible to participate in the STARTRK-2 Study. Take 1 minute to use our Evaluation Tool and consider your patients' eligibility.
Read on to find out more about entrectinib and no-cost diagnostic testing.
Know what to expect along the way:
Determine patient eligibility using the Evaluation tool
Obtain patient consent and arrange delivery of biopsy specimen(s)
Trailblaze Pharos™ assay will identify whether NTRK1, NTRK2, NTRK3, ROS1, or ALK gene rearrangements are present
Review Pharos Report™ and counsel patient on results
Get connected with nearest clinical trial site to proceed with formal determination of eligibility and potential enrollment
Entrectinib, targeted action for NTRK1, NTRK2, NTRK3, ROS1, and ALK
This small-molecule drug is designed to target the intracellular domain of specific tyrosine kinase receptors that have been constitutively activated through genetic alteration in order to restrict abnormal cell signaling. Scroll down to view the believed mechanism of action.
Did you know that many point mutations are largely inconsequential to cancer progression? They are often considered passengers, while large-scale genetic alterations frequently drive cancer progression.
[icons for 6 major tumor types of interest and this text]
Did you know that the STARTRK-2 trial is studying patients with a variety of cancer types? Click here to learn more
See if your patients may be eligible to participate in the STARTRK-2 Study. Click here to learn more