PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib ON-TRK

What's the purpose of this trial?

In this observational study researchers 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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Enrollment: 150 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Open and Accepting

Banner Desert Medical Center

Mesa, AZ

Open and Accepting

California

California Research Inst.

Los Angeles, CA

Open and Accepting

USC Norris Comprehensive Cancer Center - Keck School of Medicine University of Southern California

Los Angeles, CA

Open and Accepting

UCLA - Mattel Children's Hospital

Los Angeles, CA

Open and Accepting

Hoag Memorial Hospital Presbyterian

Newport Beach, CA

Open and Accepting

UCSF Benioff Children's Hospital Oakland

Oakland, CA

Open and Accepting

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

Palo Alto, CA

Open and Accepting

Providence Saint John's Cancer Institute

Santa Monica, CA

Open and Accepting

Colorado

SCL Health St. Mary's Medical Center

Grand Junction, CO

Open and Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Nemours Children's Hospital

Orlando, FL

Open and Accepting

Indiana

Fort Wayne Medical Oncology and Hematology (Fort Wayne North) Fort Wayne North Office

Fort Wayne, IN

Open and Accepting

Regional Health - The Hope Center

Terre Haute, IN

Open and Accepting

Kansas

Cancer Center of Kansas - Medical Arts Tower

Wichita, KS

Open and Accepting

Maine

MaineHealth Cancer Care - South Portland

South Portland, ME

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Boston Children's Hospital

Boston, MA

Open and Accepting

Michigan

Detroit Clinical Research Center

Farmington Hills, MI

Open and Accepting

Sparrow Hospital

Lansing, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Great Lakes Cancer Center

Buffalo, NY

Open and Accepting

Memorial Sloan Kettering Children's Cancer Center

New York, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

East Carolina University Vidant Cancer Care Eddie and Jo Allison Smith Tower

Greenville, NC

Open and Accepting

Ohio

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Mercy Health Youngstown

Youngstown, OH

Open and Accepting

Pennsylvania

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

Philadelphia, PA

Open and Accepting

Allegheny General Hospital

Pittsburgh, PA

Open and Accepting

South Carolina

Medical University of South Carolina

Charleston, SC

Open and Accepting

Texas

UT Southwestern Medical Center / Children's Health

Dallas, TX

Open and Accepting

Utah

Intermountain Medical Center

Murray, UT

Open and Accepting

Intermountain Healthcare - Dixie Regional Medical Center - East Campus

Salt Lake City, UT

Open and Accepting

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Washington

Seattle Children's Hospital

Seattle, WA

Open and Accepting

West Virginia

WVU Cancer Institute Mary Babb Randolph Cancer Center

Morgantown, WV

Open and Accepting

Wisconsin

Gundersen Lutheran Medical Center

La Crosse, WI

Open and Accepting
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