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Larotrectinib for Advanced Cancer
Study Summary
This trial is testing larotrectinib, which may stop the growth of cancer cells, in patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread and come back or do not respond to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not taken any NTRK inhibitor medications.My bilirubin levels are within the normal range for my age.I am not taking medication that strongly affects liver enzyme CYP3A4.My cancer can be seen on scans, or if I have neuroblastoma, it shows up on MIBG scans.I have recovered from side effects of my previous cancer treatments.My white blood cell count is healthy.I am not taking medication to prevent GVHD after a bone marrow transplant.My kidney function test shows a clearance rate of at least 70 ml/min.I am mostly able to care for myself and carry out daily activities.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I do not have any infections that are not under control.I am enrolled in APEC1621SC and assigned to MATCH for an actionable mutation.I have not taken TRK inhibitors like entrectinib for my condition.I am between 12 and 21 years old.
- Group 1: Treatment (larotrectinib sulfate)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Larotrectinib for use in clinical settings?
"Larotrectinib's safety has been assessed as a 2, since it is currently in Phase 2 with limited evidence of efficacy but some data confirming its security."
Who is eligible to take part in this investigation?
"This medical trial seeks 49 minors aged between 12 months and 21 years old with Wilms Tumor who have been assigned to the Molecular Analysis for Therapy Choice (MATCH) treatment via APEC1621SC. Eligibility also hinges on a Karnofsky score of 50 or higher in patients over 16, while those under 16 require a Lansky score of at least that much. Moreover, individuals must be recovered from prior therapies' toxic side effects; if they meet all other criteria after the required time frame has elapsed, they are considered ready to enroll."
Is this experiment currently open to participants?
"Affirmative, clinicaltrials.gov confirms that the trial is presently recruiting patients; this study was initially posted on July 24th 2017 and has been recently updated on November 30th 2022. In total, the medical team requires 49 volunteers from 100 different sites to participate in their research."
Are individuals younger than 20 years old considered for this research study?
"The accepted range of participant ages for this trial is 12 Months to 21 Years."
Could you provide an overview of the research conducted on Larotrectinib?
"Presently, there are 71 Larotrectinib trials in progress with 31 at the Phase 3 stage. Most of these experiments are located around Peoria, Illinois; however, the drug is being tested across 10220 locations globally."
What medical conditions are commonly treated using Larotrectinib?
"Larotrectinib has been clinically approved to treat neoplasms with NTRK3 and/or NTRK2 fusion gene mutations."
Could you enumerate the locations undergirding this clinical investigation?
"Currently, this trial is ran by 100 separate medical centres. These sites are spread across Madison, Marshfield and East Lansing as well as other cities. To limit the need for travel while participating in the study, it's advisable to find a site near you."
How many participants have been included in this medical study?
"Affirmative, the information on clinicaltrials.gov illustrates that recruitment for this research is still happening. The trial was initially posted in July 2017 and latest updated at the end of November 2022; seeking 49 participants from 100 distinct sites."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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