VITRAKVI for Solid Tumors
(ON-TRK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and effectiveness of the drug VITRAKVI (larotrectinib) for individuals with TRK fusion cancer that has spread or is advanced. TRK fusion cancer results from a specific genetic change that causes uncontrolled cell growth, forming tumors. The trial includes groups with lung, head and neck, or central nervous system cancers. Suitable candidates have a solid tumor with this genetic change and have already decided with their doctor to use VITRAKVI for treatment. Researchers will observe participants' health and treatment progress over several years to gather more insights.
As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new cancer therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor, as they will consider your specific situation.
What is the safety track record for VITRAKVI (larotrectinib)?
Research shows that VITRAKVI (larotrectinib) is generally well-tolerated, but some side effects require attention. Common side effects include fatigue, nausea, dizziness, vomiting, and changes in liver function tests, occurring in at least 20% of patients.
Some patients experienced neurological effects, such as dizziness and changes in thinking. Serious liver problems have also been reported, so liver function should be monitored during treatment.
Overall, while VITRAKVI is considered safe for use, prospective trial participants should consult their doctor about possible side effects to determine if it is the right choice.12345Why are researchers excited about this trial?
Larotrectinib is unique because it specifically targets TRK fusion proteins, which are present in a variety of cancers but not targeted by most conventional treatments. Unlike standard care options that often involve chemotherapy or targeted therapies aimed at specific cancer types, larotrectinib works across different tumor types by focusing on a genetic abnormality common to them. Researchers are excited about larotrectinib because it offers a more personalized approach, potentially leading to effective treatment outcomes regardless of the cancer's location in the body. This broad applicability and precision make it a promising option for patients with TRK fusion cancers.
What is the effectiveness track record for VITRAKVI in treating TRK fusion cancer?
Research has shown that larotrectinib, also known as VITRAKVI, is highly effective in treating TRK fusion cancers. Studies have found that larotrectinib benefits patients of all ages and tumor types, leading to significant and lasting improvements. Many patients experience a noticeable reduction in tumor size. For children, the success rate is particularly high, with 87% showing positive results. This medication blocks abnormal proteins that cause cancer to grow, helping patients live longer with fewer side effects. In this trial, researchers are studying larotrectinib across various treatment arms, including those for soft tissue sarcoma, primary central nervous system cancer, lung cancer, head and neck cancer, gastrointestinal cancer, melanoma, and other tumor types, as well as a pediatric cohort.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VITRAKVI as part of their routine medical care for TRK fusion cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Larotrectinib
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
patients with other tumor types
adult patients with soft tissue sarcoma (STS)
all pediatric patients regardless of tumor type will be enrolled under this cohort
adult patients with melanoma
adult patients with lung cancer
adult patients with head and neck (H\&N) cancer
adult patients with gastrointestinal (GI) cancer
adult patients with primary central nervous system (CNS) cancer
Larotrectinib is already approved in United States, European Union for the following indications:
- Solid tumors with NTRK gene fusions
- Solid tumors with NTRK gene fusions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
Efficacy and safety of larotrectinib in TRK fusion-positive ...
In patients with TRK fusion-positive CNS tumors, larotrectinib demonstrated rapid and durable responses, high disease control rate, and a favorable safety ...
627P Long-term efficacy and safety of larotrectinib in non- ...
We report long-term efficacy and safety data in adult and paediatric pts with non-primary CNS TRK fusion cancer. Methods. Data were pooled from 3 larotrectinib ...
Efficacy and safety of larotrectinib in patients with non- ...
Laro continues to demonstrate rapid and durable responses, extended survival, clinical benefit, and a favorable safety profile in pts with TRK fusion cancer.
Efficacy of Larotrectinib in TRK Fusion–Positive Cancers ...
Larotrectinib had marked and durable antitumor activity in patients with TRK fusion–positive cancer, regardless of the age of the patient or of the tumor type.
NCT02576431 | A Study to Test the Effect of the Drug ...
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a ...
Side Effects of VITRAKVI® (larotrectinib) | Official Patient Site
VITRAKVI may cause serious side effects, including: Liver problems. Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious.
Safety Profile | VITRAKVI® (larotrectinib) | HCP Site
Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive ...
Vitrakvi (larotrectinib) - accessdata.fda.gov
most common adverse reactions (≥ 20%) with VITRAKVI were fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation, and diarrhea.
Larotrectinib: MedlinePlus Drug Information
Larotrectinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: · cough · constipation · diarrhea ...
Larotrectinib sulfate: uses, dosing, warnings, adverse ...
Adverse effects reported in >20% of patients receiving larotrectinib include increased AST concentrations, increased ALT concentrations, anemia, ...
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