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Kinase Inhibitor
Larotrectinib for Advanced or Metastatic Cancer
Phase 2
Recruiting
Led By David S Hong
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have received prior treatment including radiation and/or chemotherapy, with radiation completed > 12 weeks prior to cycle 1 day 1 (C1D1) of therapy, as recommended or appropriate for the tumor type
Must have >= 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging [MRI] and evaluable by RANO), with the size of at least one of the measurable lesions >= 1 cm in each dimension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights
Study Summary
This trial studies the effect of larotrectinib in treating patients with NTRK gene amplification positive solid tumors. Larotrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults (16+) with solid tumors that have spread and show NTRK gene amplification. Participants must have tried standard treatments, or be unlikely to benefit from them, and should not have progressed on TRK inhibitors before. They need stable organ function, measurable tumor lesions, no uncontrolled infections or diseases, and agree to use two birth control methods.Check my eligibility
What is being tested?
The trial tests Larotrectinib's effectiveness in blocking enzymes needed for cell growth in patients with advanced solid tumors positive for NTRK gene amplification. It's a phase II study where all participants receive the same drug to see how well it works against their cancer.See study design
What are the potential side effects?
Larotrectinib may cause liver enzyme changes, fatigue, dizziness, nausea. Since it targets specific enzymes linked to cell growth, there might also be risks of more serious side effects like heart problems or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had radiation or chemotherapy for my cancer, with radiation ending more than 12 weeks ago.
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I have a tumor that is at least 1 cm big in every direction, confirmed by MRI.
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My cancer has a specific gene change (NTRK1, NTRK2, or NTRK3) with at least 7 copies.
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I am 16 years old or older.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response
Secondary outcome measures
Best overall response of confirmed complete response or partial response
Change in clinical safety laboratory values and vital signs
Clinical benefit rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (larotrectinib sulfate)Experimental Treatment1 Intervention
Patients receive larotrectinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of unacceptable toxicity. Patients who experience disease progression and are deriving clinical benefit from larotrectinib may continue treatment per physician discretion.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,333 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,841 Total Patients Enrolled
David S HongPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
267 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've previously had cancer treatment that didn't work, but stopped if it was intolerable within 28 days.I haven't taken any cancer drugs or been in a trial for at least 2 weeks.I do not have any uncontrolled infections or unstable heart conditions.I cannot stop taking a strong medication that affects liver enzymes before starting treatment.I've had radiation or chemotherapy for my cancer, with radiation ending more than 12 weeks ago.I've had standard treatment for my cancer or it's believed I won't benefit from it.My blood pressure remains high (>150/100 mmHg) despite taking medication.I agree to use two forms of birth control during and 3 months after the study.I have a tumor that is at least 1 cm big in every direction, confirmed by MRI.My cancer has a specific gene change (NTRK1, NTRK2, or NTRK3) with at least 7 copies.I've had a scan within the last 28 days and haven't changed my steroid dose in the last 5 days.I can care for myself but may not be able to do active work.I do not have any other cancers that would interfere with this study, except for minor skin, cervical, breast, bladder, or prostate cancers.I can provide samples of my tumor, either from previous surgeries or through a new biopsy.My bilirubin levels are within the normal range, or I have Gilbert's disease with only indirect bilirubin elevated.I have brain metastases but don't need steroids to manage symptoms.I have not had a stroke in the last 3 months.I have had a heart attack in the last 3 months.I am 16 years old or older.I have a tumor that can be measured by standard criteria.My kidney function is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (larotrectinib sulfate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedential investigations that have utilized Larotrectinib Sulfate?
"71 separate medical trials are currently in progress evaluating Larotrectinib Sulfate, with 31 of these studies being conducted at the Phase 3 stage. While Peoria Illinois is home to a majority of the research initiatives for this particular drug, there are 10220 sites globally hosting related clinical trial activities."
Answered by AI
What therapeutic applications is Larotrectinib Sulfate regularly utilized for?
"Larotrectinib Sulfate is frequently prescribed to treat ntrk3 fusion positive conditions. In addition, this medication has been associated with beneficial outcomes in patients suffering from tumors, solid malignancies, and ntrk2 fusion positive cases that have not developed resistance mutations."
Answered by AI
What is the maximum capacity of participants for this scientific research?
"Affirmative. Information on clinicaltrials.gov shows that this experiment, first made available to the public on April 30th 2021, is actively soliciting participants. The research team needs 13 people from a single site for the study's completion."
Answered by AI
Are any more individuals being admitted to this experiment?
"Per information hosted on clinicaltrials.gov, this investigation is accepting applicants; the protocol was initially published on April 30th 2021 and amended as recently as April 18th 2022."
Answered by AI
Has the FDA accepted Larotrectinib Sulfate for commercial use?
"Our team at Power assessed Larotrectinib Sulfate's safety as a 2 since the trial is in Phase 2, meaning there are some studies backing its safety but no evidence of efficacy."
Answered by AI
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