Entrectinib for Solid Tumors
(STARTRK-NG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of starting the trial. It's best to discuss your current medications with the trial team.
Is Entrectinib safe for humans?
Entrectinib, also known as Rozlytrek, is generally well tolerated in humans, with a manageable safety profile. Common side effects include changes in taste, tiredness, dizziness, constipation, diarrhea, nausea, weight gain, tingling sensations, increased creatinine levels, muscle pain, swelling, vomiting, joint pain, anemia, and increased liver enzymes.12345
How is the drug Entrectinib unique for treating solid tumors?
Entrectinib is unique because it targets specific genetic changes in tumors, known as NTRK, ROS1, and ALK gene fusions, which are not commonly targeted by other treatments. This makes it a personalized treatment option for patients with these specific genetic alterations in their solid tumors.678910
What data supports the effectiveness of the drug Entrectinib (Rozlytrek) for solid tumors?
Entrectinib has been shown to be effective in treating solid tumors with specific genetic changes (NTRK and ROS1 gene fusions) and is approved for use in both adults and children. It has demonstrated meaningful and lasting responses in patients, including those with cancer that has spread to the brain.1251112
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for children and adolescents with advanced or metastatic solid tumors or primary CNS tumors that have specific gene fusions (NTRK1/2/3 or ROS1) and no satisfactory treatment options. They must have a certain level of physical function, recovered from previous treatments, adequate organ function, not be pregnant or breastfeeding, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors
Phase 2 Treatment
Expansion cohorts in patients with primary brain tumors and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Entrectinib
Entrectinib is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University