Larotrectinib for NTRK Amplification Positive Solid Tumors
This study is testing a drug called larotrectinib in people with solid tumors that have spread to nearby tissues (locally advanced) or other parts of the body (metastatic). These tumors must also have a specific genetic change called an NTRK gene amplification. Larotrectinib works by blocking certain enzymes that help tumor cells grow. The study aims to see how many patients respond to larotrectinib, meaning their tumors shrink or disappear. You may be able to join if you are at least 16 years old and have a locally advanced or metastatic solid tumor with an NTRK gene amplification. The study plans to enroll 13 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a Phase II trial, which typically involves a smaller number of participants to evaluate the drug's effectiveness and safety.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure overall response for up to 2 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04879121
Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors
Recruiting
PHASE2Ages 16+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~13 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Larotrectinib Sulfate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response
Measured over Up to 2 years post-treatment
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- David S Hong · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
David S. Hong
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
At least 16 years of age
Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene amplification identified through molecular assays (such as IHC and any next-generation sequencing \[NGS\] platform, reference lab NGS, or in house NGS platform) as routinely performed at The University of Texas MD Anderson Cancer Center or other similarly-certified laboratories. The minimum level of amplification is 7 copies. This rationale of amplification level is based on data from MOCLIA at The University of Texas MD Anderson Cancer Center
Must have received prior standard therapy appropriate for tumor type and stage of disease, or, in the opinion of the investigator, is unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy
Must have at least one measurable lesion as defined by RECIST v1.1. Subjects with primary CNS tumors should meet the following criteria:
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
Must have imaging study within 28 days before enrollment. If on steroid therapy, the dose must be stable for at least five days immediately before and during the imaging study
Eastern Cooperative Oncology Group (ECOG) score =\< 3. If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky performance score (KPS) \>= 70 %
Archived tumor tissue. If archival tissue is unavailable, an on-study tumor biopsy should be attempted if it can be safely performed
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) or \< 5 x ULN if liver function abnormalities are due to underlying malignancy
Total bilirubin \< 2.5 x ULN, except in cases of biliary obstruction. Subjects with a known history of Gilberts disease and an isolated elevation of indirect bilirubin are eligible
Serum creatinine \< 2.0 x ULN or estimated glomerular filtration rate \>= 30 mL/minute using the Cockcroft-Gault formula
Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
Willingness of men and women of reproductive potential to use two effective birth control methods, one used by the subject and another by his/her partner, for the duration of treatment and for 3 months following study completion
Exclusion
Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or five half-lives, whichever is shorter, and without clinically significant toxicities from that therapy
Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. However, subjects who received less than 28 days of such treatment and discontinued because of intolerance or toxicity are eligible
Symptomatic or unstable brain metastases that needs corticosteroid usage. Subjects with asymptomatic brain metastases or primary CNS tumors are eligible
Uncontrolled concurrent malignancy that would limit assessment of efficacy. Allowed diseases may include, but are not limited to in situ cancers of cervix, breast, or skin, superficial bladder cancer, limited-stage prostate cancer, and basal or squamous cancers of the skin
Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease or other systemic disease that would limit compliance with study procedures. Unstable cardiovascular disease is defined as:
Persistently uncontrolled hypertension defined as systolic blood pressure (BP) \> 150 mmHg and/or diastolic BP \> 100 mmHg despite antihypertensive therapy
Myocardial infarction within 3 months of screening
Stroke within 3 months of screening
Inability to discontinue treatment with a strong cytochrome P450 (CYP450), 3A4 (CYP3A4) inhibitor or inducer prior to start of treatment
Pregnancy or lactation
What this trial measures
- Overall responseUp to 2 years post-treatment
Will be scored by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.