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

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.

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study Overview

Study Details

Study overview

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.

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

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

Condition
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Intervention / Treatment

-

Contacts and Locations

Mesa

Banner Desert Medical Center, Mesa, Arizona, United States, 85202

Los Angeles

California Research Inst., Los Angeles, California, United States, 90027

Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90089

Los Angeles

UCLA - Mattel Children's Hospital, Los Angeles, California, United States, 90095

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 82663

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

Palo Alto

Stanford Univ Med Ctr. / Lucile Packard Children's Hosp, Palo Alto, California, United States, 94304

Santa Monica

Providence Health System - Southern California, Santa Monica, California, United States, 90404

Torrance

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Grand Junction

SCL Health, Grand Junction, Colorado, United States, 81501

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bayer,

Study Record Dates

2030-03-31