Recruiting

VITRAKVI

Sponsor:

Bayer

Code:

NCT04142437

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

larotrectinib(Vitrakvi, BAY2757556)

Study Details

Brief summary:

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study ID

NCT04142437

Start date

Apr 3, 2020

Status verified date

Jul, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult and pediatric (from birth to 18-year-old) patients
  • Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
  • Life expectancy of at least 3 months based on clinical judgement
  • Decision to treat with larotrectinib made by the treating physician prior to study enrollment
  • Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
  • Signed informed consent form
  • For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

  • Any contraindications as listed in the local approved product information
  • Pregnancy
  • Participation in an investigational program with interventions outside of routine clinical practice
  • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
  • Patients with NTRK gene amplification or NTRK point mutation

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

GI

adult patients with gastrointestinal (GI) cancer

H&N

adult patients with head and neck (H\&N) cancer

STS

adult patients with soft tissue sarcoma (STS)

CNS

adult patients with primary central nervous system (CNS) cancer

Lung

adult patients with lung cancer

Melanoma

adult patients with melanoma

Pediatric

all pediatric patients regardless of tumor type will be enrolled under this cohort

other

patients with other tumor types

Interventions

larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]
  • Severity of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Seriousness of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Reasonable causal relationship between larotrectinib and an AE [ Time Frame: Up to 30 days after last dose ]
  • Causality of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Action taken related to larotrectinib treatment [ Time Frame: Up to 30 days after last dose ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

(+)1-888-84 22937clinical-trials-contact@bayer.com

Locations

California Research Inst.

Recruiting

Los Angeles, California, United States, 90027

UCLA - Mattel Children's Hospital

Recruiting

Los Angeles, California, United States, 90095

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 82663

Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

Recruiting

Palo Alto, California, United States, 94304

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

University of Miami

Recruiting

Miami, Florida, United States, 33146

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Fort Wayne Medical Oncology Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Maine Health

Recruiting

South Portland, Maine, United States, 04106

Johns Hopkins / Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21205

Tufts / Neely Cancer Center

Recruiting

Boston, Massachusetts, United States, 02111

Detroit Clinical Research Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Sparrow Cancer Center

Recruiting

Lansing, Michigan, United States, 48912

Nevada Cancer Research Foundation

Recruiting

Las Vegas, Nevada, United States, 89169

Memorial Sloan Kettering Children's Cancer Center

Recruiting

New York, New York, United States, 10065

East Carolina University / Vidant Health

Recruiting

Greenville, North Carolina, United States, 27834

Mercy Health Youngstown

Recruiting

Youngstown, Ohio, United States, 44501

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Medical Univ. of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

UT Southwestern Medical Center / Children's Health

Recruiting

Dallas, Texas, United States, 75390

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Univ. of Utah / Huntsman Cancer Center

Recruiting

Salt Lake City, Utah, United States, 84112

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Gundersen Health System

Recruiting

La Crosse, Wisconsin, United States, 54601

More Information

Sponsor

Bayer

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bayer on 2026-07-07.