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Active, not recruiting Phase 2 Interventional Results available

Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

ClinicalTrials.gov ID: NCT03834961

Public ClinicalTrials.gov record NCT03834961. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II trial studies the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.

Study identification

NCT ID
NCT03834961
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Children's Oncology Group
Network
Enrollment
33 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 25, 2019 (Actual)
Primary completion
Sep 30, 2024 (Actual)
Completion
Jul 25, 2027 (Estimated)
Last update posted
Dec 2, 2025

2019 – 2027

United States locations

U.S. sites
78
U.S. states
39
U.S. cities
70
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 —
Kaiser Permanente Downey Medical Center Downey California 90242 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Kaiser Permanente-Oakland Oakland California 94611 —
Children's Hospital of Orange County Orange California 92868 —
UCSF Medical Center-Mission Bay San Francisco California 94158 —
Children's Hospital Colorado Aurora Colorado 80045 —
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 —
Yale University New Haven Connecticut 06520 —
Alfred I duPont Hospital for Children Wilmington Delaware 19803 —
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Broward Health Medical Center Fort Lauderdale Florida 33316 —
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 —
University of Florida Health Science Center - Gainesville Gainesville Florida 32610 —
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 —
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 —
Nicklaus Children's Hospital Miami Florida 33155 —
Nemours Children's Hospital Orlando Florida 32827 —
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 —
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Saint Luke's Cancer Institute - Boise Boise Idaho 83712 —
Saint Jude Midwest Affiliate Peoria Illinois 61637 —
Riley Hospital for Children Indianapolis Indiana 46202 —
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 —
Norton Children's Hospital Louisville Kentucky 40202 —
Ochsner Medical Center Jefferson New Orleans Louisiana 70121 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
C S Mott Children's Hospital Ann Arbor Michigan 48109 —
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 —
Mayo Clinic in Rochester Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 —
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 —
Washington University School of Medicine St Louis Missouri 63110 —
Mercy Hospital Saint Louis St Louis Missouri 63141 —
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Morristown Medical Center Morristown New Jersey 07960 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Montefiore Medical Center - Moses Campus The Bronx New York 10467 —
Mission Hospital Asheville North Carolina 28801 —
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 —
Novant Health Presbyterian Medical Center Charlotte North Carolina 28204 —
Children's Hospital Medical Center of Akron Akron Ohio 44308 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Dayton Children's Hospital Dayton Ohio 45404 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Oregon Health and Science University Portland Oregon 97239 —
Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania 18103 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
Rhode Island Hospital Providence Rhode Island 02903 —
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 —
Saint Jude Children's Research Hospital Memphis Tennessee 38105 —
Dell Children's Medical Center of Central Texas Austin Texas 78723 —
Medical City Dallas Hospital Dallas Texas 75230 —
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 —
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —
Primary Children's Hospital Salt Lake City Utah 84113 —
Children's Hospital of The King's Daughters Norfolk Virginia 23507 —
Seattle Children's Hospital Seattle Washington 98105 —
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 —
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 —
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 —
Marshfield Medical Center-Marshfield Marshfield Wisconsin 54449 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03834961, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 2, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03834961 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →