Actively Recruiting
Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
13
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of larotrectinib in treating patients with NTRK gene amplification positive solid tumors that have spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic). Larotrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 16 years of age
- Locally advanced or metastatic cancer with NTRK1, NTRK2, or NTRK3 gene amplification confirmed by molecular testing
- Prior standard therapy received or deemed unlikely to benefit from standard care
- At least one measurable tumor lesion as defined by RECIST v1.1 or RANO for CNS tumors
- For primary CNS tumors, prior radiation and/or chemotherapy completed more than 12 weeks before treatment start
- Karnofsky performance score of 70% or higher if primary CNS tumor
- Imaging study within 28 days before enrollment; stable steroid dose if applicable
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 3
- Availability of archived tumor tissue or willingness to undergo biopsy
- Liver enzymes (AST and ALT) less than 2.5 times upper limit of normal (ULN) or less than 5 times ULN if due to cancer
- Total bilirubin less than 2.5 times ULN except in biliary obstruction; Gilbert's disease allowed with isolated indirect bilirubin elevation
- Serum creatinine less than 2.0 times ULN or estimated glomerular filtration rate at least 30 mL/min
- Ability to comply with outpatient treatment, lab monitoring, and clinic visits
- Willingness to use two effective birth control methods during treatment and for 3 months after
You will not qualify if you...
- Use of investigational or anticancer therapy within 2 weeks or five half-lives before starting larotrectinib
- Prior disease progression while on TRK-targeting tyrosine kinase inhibitors, unless discontinued within 28 days due to intolerance or toxicity
- Symptomatic or unstable brain metastases requiring corticosteroids
- Uncontrolled other cancers that limit assessment of efficacy
- Active uncontrolled infections or unstable cardiovascular or systemic diseases
- Persistently uncontrolled hypertension despite treatment
- Myocardial infarction or stroke within 3 months before screening
- Inability to stop strong CYP3A4 inhibitors or inducers before treatment
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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