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NCT04142437Recruiting

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI 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

Bayer

Start Date

4/3/2020

Completion Date

3/31/2030

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

larotrectinib(Vitrakvi, BAY2757556)

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Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Locations

Banner Desert Medical Center

Mesa, Arizona 85202

United States

California Research Inst.

Los Angeles, California 90027

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California 90089

United States

UCLA - Mattel Children's Hospital

Los Angeles, California 90095

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 82663

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California 94609

United States

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

Palo Alto, California 94304

United States

Providence Health System - Southern California

Santa Monica, California 90404

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California 90502

United States

SCL Health

Grand Junction, Colorado 81501

United States

Yale University

New Haven, Connecticut 06520

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

University of Miami

Miami, Florida 33146

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

Nemours Children's Hospital

Orlando, Florida 32827

United States

Fort Wayne Medical Oncology Hematology

Fort Wayne, Indiana 46804

United States

Regional Health Hope Center

Terre Haute, Indiana 47802

United States

Cancer Center of Kansas

Wichita, Kansas 67214

United States

Maine Health

South Portland, Maine 04106

United States

Univ. of Maryland / Greenebaum Comp. Cancer Ctr.

Baltimore, Maryland 21201

United States

Johns Hopkins / Sidney Kimmel Cancer Center

Baltimore, Maryland 21205

United States

Frederick Health-James M Stockman Cancer Institute

Frederick, Maryland 21702

United States

Tufts / Neely Cancer Center

Boston, Massachusetts 02111

United States

Boston Children's / Dana Farber

Boston, Massachusetts 02215

United States

Detroit Clinical Research Center

Farmington Hills, Michigan 48334

United States

Sparrow Cancer Center

Lansing, Michigan 48912

United States

Nevada Cancer Research Foundation

Las Vegas, Nevada 89169

United States

Atlantic Hem Onc / Morristown Medical Center

Morristown, New Jersey 07960

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Great Lakes Cancer Center

Buffalo, New York 14210

United States

Memorial Sloan Kettering Children's Cancer Center

New York, New York 10065

United States

Staten Island Univ. Hospital (Northwell Health)

Staten Island, New York 10305

United States

Levine Cancer Center

Charlotte, North Carolina 28204

United States

East Carolina University / Vidant Health

Greenville, North Carolina 27834

United States

Ohio State Comp. Cancer Ctr. / James Cancer Hospital

Columbus, Ohio 43210

United States

Mercy Health Youngstown

Youngstown, Ohio 44501

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

University of Pennsylvania (Penn Med)

Philadelphia, Pennsylvania 19104

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Medical Univ. of South Carolina

Charleston, South Carolina 29425

United States

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

UT Southwestern Medical Center / Children's Health

Dallas, Texas 75390

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Intermountain Healthcare - Intermountain Medical Center

Murray, Utah 84107

United States

Univ. of Utah / Huntsman Cancer Center

Salt Lake City, Utah 84112

United States

Intermountain Healthcare - Dixie Regional Medical Center

St. George, Utah 84790

United States

Seattle Children's

Seattle, Washington 98105

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Gundersen Health System

La Crosse, Wisconsin 54601

United States

SSM Health Cancer Center - Dean Medical Group

Madison, Wisconsin 53717

United States

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