About the STARTRK-2 Study
Is the STARTRK-2 cancer clinical trial right for you?
What is the Process for Trial Enrollment?
See if you are eligible for this study.
Talk to your doctor about the STARTRK-2 trial using our Doctor Discussion Guide.
Learn more about the Trailblaze Pharos™ diagnostic test and get tested.
Review the resulting Trailblaze Report™ with your doctor.
Get connected with the nearest trial site to undergo additional screening for enrollment in the trial.
Who can participate in STARTRK-2?
Participants in the STARTRK-2 trial will be matched with a team of experts for study-related medical care.
This trial is open to adults (18 years old or older) diagnosed with locally advanced or metastatic tumors caused by specific genetic rearrangements. Learn what additional factors make a person eligible to come on board.
Further criteria for acceptance:
Biopsy testing results confirming ALK, ROS1, or NTRK gene fusions.
Your doctor can use our no-cost Trailblaze Pharos™ test or another locally available diagnostic test to determine this.
Patients who have undergone prior cancer therapy are allowed, provided they were not treated with other drugs in the same class as entrectinib.
Take a few minutes to use our Evaluation tool and let us know that you are interested in STARTRK-2.
Are there possible side effects or risks to participants in this clinical study?
Here's what we know about safety from Phase 1:
In Phase 1 trials, 119 patients were given entrectinib. The most frequently reported side-effects are listed below. Most side-effects were mild or moderate in severity and could be managed with change in dose if necessary:
Tingling of hands or feet
Entrectinib is an investigational therapy, so we are still learning about other potential side effects in different people. You may experience a side effect that is not included in the list above.
What has Phase 1 revealed so far?
A recent Phase 1 study update, consisting of a total of 119 patients with a range of solid tumors, demonstrated that entrectinib appeared to be well tolerated, with the most frequent adverse events consisting of mild to moderate fatigue, altered taste, abnormal sensations in the nerves, nausea, and muscle aches. In terms of tumor response, there were 24 patients treated who had tumors that were positive for an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion, had not previously received inhibitors of these targets and received an efficacious dose of entrectinib. Among these 24 patients, 19 patients (79%) had a confirmed RECIST tumor response. In addition, one patient with a primary brain tumor also had evidence of tumor regression. Many of these responses occurred rapidly, within the first four weeks of entrectinib treatment. Seventeen of the patients remained on study treatment, having received up to 27 months of treatment.
How long will my participation on the trial last?
Participants will be treated with entrectinib continuously for as long as they are deriving clinical benefit.
Any safety concerns will be addressed immediately whenever they arise by your study team.
Participants can choose to withdraw from the trial at any time.
Will patients have to pay for diagnostic testing or medication?
Depending on the policies at each clinical trial site, health insurance copays may be required for study-related diagnostic testing and for any non-study-related medication. The study drug entrectinib will be provided to all participants at no-cost.
Will patients be compensated for their participation in the trial?
Will a patient have to travel long distances to see his/her STARTRK-2 study team?
Ignyta has worked with medical institutions across the country to establish many trial sites. Each of these sites is held to the same standards of excellence.
Many more sites are planned to open in the future so check our Study Locator Page often.
Participants in the trial may also qualify for travel assistance where necessary.
Who is responsible for follow-up with patients enrolled in the trial?
Trial participants must go to the trial site for all ongoing study visits. You should continue to see your regular doctor(s) for all other medical care.
Who should be contacted for support or additional information?
See if you or a loved one may be eligible for the study.