Trial Condition(s):

locally advanced or metastatic solid tumor harboring an NTRK gene fusion

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 (ON-TRK)

Bayer Identifier:

20324

ClinicalTrials.gov Identifier:

NCT04142437

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

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
- 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

Trial Summary

Enrollment Goal
300
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Canada

Status
Recruiting
 
Locations

MD Anderson Cancer Center

Gilbert, United States, 85234

Status
Recruiting
 
Locations

Hoag Memorial Hospital Presbyterian

Newport Beach, United States, 82663

Status
Recruiting
 
Locations

UT Southwestern Medical Center / Children's Health

Dallas, United States, 75390

Status
Recruiting
 
Locations

UCLA - Mattel Children's Hospital

Los Angeles, United States, 90095

Status
Recruiting
 
Locations

St. Jude Children's Research Hospital

Memphis, United States, 38105

Status
Recruiting
 
Locations

Regional Health Hope Center

Terre Haute, United States, 47802

Status
Recruiting
 
Locations

University of Pennsylvania (Penn Med)

Philadelphia, United States, 19104

Status
Recruiting
 
Locations

Seattle Children's

Seattle, United States, 98105

Status
Recruiting
 
Locations

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

Palo Alto, United States, 94304

Status
Recruiting
 
Locations

Johns Hopkins / Sidney Kimmel Cancer Center

Baltimore, United States, 21287

Status
Recruiting
 
Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, United States, 90027

Status
Recruiting
 
Locations

Nemours Children's Hospital

Orlando, United States, 32827

Status
Recruiting
 
Locations

Intermountain Healthcare - Intermountain Medical Center

Murray, United States, 84107

Status
Recruiting
 
Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, United States, 08901

Status
Recruiting
 
Locations

Staten Island Univ. Hospital (Northwell Health)

Staten Island, United States, 10305

Status
Recruiting
 
Locations

Banner Desert Medical Center

Mesa, United States, 05202

Status
Recruiting
 
Locations

University of Miami

Plantation, United States, 33324

Status
Recruiting
 
Locations

Yale University

New Haven, United States, 06520

Status
Recruiting
 
Locations

Medical Univ. of South Carolina

Charleston, United States, 29425

Status
Recruiting
 
Locations

Fort Wayne Medical Oncology Hematology

Fort Wayne, United States, 46804

Status
Recruiting
 
Locations

West Virginia University

Morgantown, United States, 26506

Status
Recruiting
 
Locations

Maine Health

South Portland, United States, 04106

Status
Recruiting
 
Locations

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, United States, 90502

Status
Recruiting
 
Locations

Univ. of Utah / Huntsman Cancer Center

Salt Lake City, United States, 84112

Status
Recruiting
 
Locations

Levine Cancer Center

Charlotte, United States, 28204

Status
Recruiting
 
Locations

Mayo Clinic

Jacksonville, United States, 32224

Status
Recruiting
 
Locations

Intermountain Healthcare - Dixie Regional Medical Center

St. George, United States, 84790

Status
Recruiting
 
Locations

Univ. of Maryland / Greenebaum Comp. Cancer Ctr.

Baltimore, United States, 21201

Status
Recruiting
 
Locations

SCL Health

Grand Junction, United States, 81501

Status
Recruiting
 
Locations

California Research Inst.

Los Angeles, United States, 90027

Status
Recruiting
 
Locations

Ohio State Comp. Cancer Ctr. / James Cancer Hospital

Columbus, United States, 43210

Status
Recruiting
 
Locations

Allegheny Health Network

Pittsburgh, United States, 15212

Status
Recruiting
 
Locations

East Carolina University / Vidant Health

Greenville, United States, 27834

Status
Recruiting
 
Locations

UCSF Benioff Children's Hospital Oakland

Oakland, United States, 94609

Status
Recruiting
 
Locations

Boston Children's / Dana Farber

Boston, United States, 02215

Status
Recruiting
 
Locations

Detroit Clinical Research Center

Farmington Hills, United States, 48334

Status
Recruiting
 
Locations

Atlantic Hem Onc / Morristown Medical Center

Morristown, United States, 07960

Status
Recruiting
 
Locations

Gundersen Health System

La Crosse, United States, 54601

Status
Recruiting
 
Locations

Sparrow Cancer Center

Lansing, United States, 48912

Status
Recruiting
 
Locations

SSM Health Cancer Center - Dean Medical Group

Madison, United States, 53717

Status
Recruiting
 
Locations

Mercy Health Youngstown

Youngstown, United States, 44501

Status
Recruiting
 
Locations

Great Lakes Cancer Center

Buffalo, United States, 14210

Status
Recruiting
 
Locations

Providence Health System - Southern California

Santa Monica, United States, 90404

Status
Recruiting
 
Locations

Memorial Sloan Kettering Children's Cancer Center

New York, United States, 10065

Status
Recruiting
 
Locations

Cancer Center of Kansas

Wichita, United States, 67214

Status
Recruiting
 
Locations

Frederick Health-James M Stockman Cancer Institute

Frederick, United States, 21702

Status
Recruiting
 
Locations

Many Locations

Many Locations, Belgium

Status
Recruiting
 
Locations

Many Locations

Many Locations, Switzerland

Status
Recruiting
 
Locations

Many Locations

Many Locations, Sweden

Status
Recruiting
 
Locations

Many Locations

Many Locations, Germany

Status
Recruiting
 
Locations

Many Locations

Many Locations, France

Status
Recruiting
 
Locations

Many Locations

Many Locations, Argentina

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Austria

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Australia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Brazil

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, China

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Denmark

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Finland

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, United Kingdom

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Greece

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Ireland

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Italy

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Japan

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, South Korea

Status
Recruiting
 
Locations

Many Locations

Many Locations, Luxembourg

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Norway

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Russia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Singapore

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Taiwan, China

Status
Not yet recruiting
 

Trial Design