RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-04-03
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04142437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult and pediatric (from birth to 18-year-old) patients
  2. * 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.
  3. * Life expectancy of at least 3 months based on clinical judgement
  4. * Decision to treat with larotrectinib made by the treating physician prior to study enrollment
  5. * Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
  6. * Signed informed consent form
  7. * For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
  1. * Any contraindications as listed in the local approved product information
  2. * Pregnancy
  3. * Participation in an investigational program with interventions outside of routine clinical practice
  4. * Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
  5. * Patients with NTRK gene amplification or NTRK point mutation

Contacts and Locations

Study Contact

Bayer Clinical Trials Contact
CONTACT
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Study Locations (Sites)

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
Intermountain Healthcare - Dixie Regional Medical Center
Saint George, Utah, 84790
United States
Univ. of Utah / Huntsman Cancer Center
Salt Lake City, Utah, 84112
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

Collaborators and Investigators

Sponsor: Bayer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-03
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2020-04-03
Study Completion Date2030-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion